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 .
Election/Restrictions
Claims 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 2, 2026.
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, 5, 6, 8, and 11 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 2-4, 7, and 9-10 depend on the above claims and, therefore, are also rejected.
With regards to claim 1, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Further, claim 1 states that the molecular weight Mw of the polyether polyol spacer, however, does not state if the molecular weight is number average or weight average, therefore, rendering the claim indefinite.
With regards to claim 5, the claim states that the molecular weight Mw, however, does not state if the molecular weight is number average or weight average, therefore, rendering the claim indefinite.
With regards to claim 6, states that the molecular weight Mw, however, does not state if the molecular weight is number average or weight average, therefore, rendering the claim indefinite.
Further, claim 6 uses the term preferably and the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Finally, with regards to claim 6, A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 6 recites the broad recitation that the composition contains a softener, and the claim also recites that the softener preferably is selected from the specifically claimed compounds, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
With regards to claim 8, the claim states that the molecular weight Mw, however, does not state if the molecular weight is number average or weight average, therefore, rendering the claim indefinite.
Further, claim 8 states “a urethan (meth)acrylate”, the term “urethan” is not clear. For purposes of compact prosecution it will be determined to be a urethane.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 8 recites the broad recitation that the composition contains a urethan (meth)acrylate, and the claim also recites that the urethan preferably is one which has the claimed molecular weight, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
With regards to claim 11, “a urethan (meth)acrylate”, the term “urethan” is not clear. For purposes of compact prosecution it will be determined to be a urethane.
Further, the claim states that the molecular weight Mn, however, does not state if the molecular weight is number average or weight average, therefore, rendering the claim indefinite.
Finally, the claim states that the molecular weight Mw, however, does not state if the molecular weight is number average or weight average, therefore, rendering the claim indefinite.
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.
Claims 1-6 and 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen et al (US 6,305,936) in view of Hoffmann et al (US 2019/0282453).
With regards to claims 1-4 and 11, Jensen teaches an isolation barrier that contains a monomer and an initiator (abstract) wherein the monomer includes triethylene glycol dimethacrylate, (column 6, line 60 to column 7 line 12) having a molecular weight of at least 600 (column 9, lines 1-11) in a concentration of 60 to 95% (column 7, lines 1-12) and wherein the initiator is a photoinitiator (column 7, lines 26-30) at a concentration from 0.01 to about 2% (column 7, lines 39-50).
Jensen is silent on the viscosity of the composition but teaches the viscosity to be low enough in order to flow into the tiny crevices and other irregularities of the surface of the tooth being treated (column 1, lines 38-45). Further, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 124 (CCPA 1955). In this case, one skilled in the art prior to the effective filing date of the present invention would know to alter the viscosity of the composition in order to achieve the desired workability balanced with the desired ability to flow into the irregularities of the surface.
Jensen does not teach the composition to contain a guanidyl containing polymer and a carrageenan.
Hoffmann teaches a medical composition that is used to isolate the gingival tissue (0007) that contains guanidinyl-containing polymer (abstract) and carrageenane(s) (0073). Hoffmann teaches the amount of guanidinyl compound to be from 1-60% (0210). Hoffmann teaches the amount of guanidyl containing polymer to be 20 parts and the amount of carrageenan to be 20 parts (0367 example 1) reading on a 1:1 ratio. Hoffman teaches the motivation for adding the combination of the guanidinyl-containing polymer and carrageenane to be because it shows an enhanced capacity of absorbing fluid, like water (0073). Jensen and Hoffman are analogous in the art of dental isolation compositions. In light of the benefit above, it would have been obvious to one skilled in the art prior to the effective filing date of the present invention to add the guanidinyl and carrageenan of Hoffman to the composition of Jensen, thereby obtaining the present invention.
With regards to claim 5, Jensen teaches that a mixture of monomers can be used in the composition (column 7, lines 1-12) and teach when other monomers are used, the concentration is less than that of the dimethacrylate (columns 11 to 13).
With regards to claim 6, Jensen teaches the addition of steryl alcohol (column 11 lines 55-64), which is known in the art as reading on a softening compound, having a molecular weight of 270.
With regards to claim 8, Jensen teaches the addition of a urethane dimethacrylate (column 12 lines 41-50).
With regards to claims 9 and 10, Jensen does not teach the claimed properties under the claimed conditions. However, when the composition recited in the reference is substantially identical to that of the claims, the claimed properties or function are presumed inherent. MPEP 2112.01. Because the prior art exemplifies Applicant’s claimed composition in that the claimed components in the claimed amounts are used, the claimed physical properties relating to the claimed tests are inherently present in the prior art. Absent an objective showing to the contrary, the addition of the claimed physical properties to the claim language fails to provide patentable distinction over the prior art.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Zech et al (US 2020/0131356) in view of Hoffmann et al (US 2019/0282453).
With regards to claims 1-4 and 11, Zech teaches a composition containing a (meth)acrylate component (0040) that has 2, 3, or 4 (meth)acrylate moieties, has a polyalkylene oxide backbone and has a molecular weight of 1,000 to 20,000 (0106-0108) and a photo initiator (abstract) and wherein the viscosity of the composition is less than 200 Pa·s. Zech teaches the amount of monomer to be 50 to 95% (0128) and the amount of photo initiator to be from 0.01 to 5% (0219).
Zech does not teach the composition to contain a guanidyl containing polymer and a carrageenan.
Hoffmann teaches a medical composition that is used to isolate the gingival tissue (0007) that contains guanidinyl-containing polymer (abstract) and carrageenane(s) (0073). Hoffmann teaches the amount of guanidinyl compound to be from 1-60% (0210). Hoffmann teaches the amount of guanidyl containing polymer to be 20 parts and the amount of carrageenan to be 20 parts (0367 example 1) reading on a 1:1 ratio. Hoffman teaches the motivation for adding the combination of the guanidinyl-containing polymer and carrageenane to be because it shows an enhanced capacity of absorbing fluid, like water (0073). Jensen and Hoffman are analogous in the art of dental isolation compositions. In light of the benefit above, it would have been obvious to one skilled in the art prior to the effective filing date of the present invention to add the guanidinyl and carrageenan of Hoffman to the composition of Jensen, thereby obtaining the present invention.
Zech does not teach the use of the composition for isolating tissue. However, 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. See MPEP 2111.02. Therefore, the addition of such statement adds no patentable weight.
With regards to claim 5, Zech teaches the addition of a second monomer, A2 (0132), having a molecular weight of 200 to 1,000 (0134) in an amount of 1 to 40% (0195).
With regards to claim 6, Zech teaches the addition of propylene glycol (0120).
With regards to claim 7, Zech teaches the addition of a dye (0221) that includes perylene (0231) and has a light absorption maximum range from 460 to 600 nm (0223-0225).
With regards to claim 8, Zech teaches the composition to contain a urethane (meth)acrylate (0139).
With regards to claim 9, Zech teaches the composition to have properties such as a viscosity of less than 200 Pa·s (0096) and a pH value of 6 to 8 (0097).
With regards to claim 10, Zech teaches the composition to have a tensile strength of 0.1 to 30 MPa (0293), an elongation at break of 50 to 500% (0294), and a shore A hardness of 30 to 90 (0293-0295).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WHITELEY whose telephone number is (571)272-5203. The examiner can normally be reached 8 - 5:00.
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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 5712721130. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JESSICA WHITELEY/Primary Examiner, Art Unit 1763
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