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 .
Status of Application
Claims 1-20 are pending and presented for examination.
Drawings
The drawings are objected to because Figures 12-15 and 17 are too blurry to read. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Abstract
The abstract of the disclosure is objected to because it should include that which is new in the art to which the invention pertains, in this instance, the components of the dental aligner. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Specification
The disclosure is objected to because of the following informalities:
The reference to a claim number should be removed in paragraph 0016 as the scope of the claims and numbering may change during the examination process.
Figures 12-17 are not appropriately described in the Brief Description of the Drawings section.
Appropriate correction is required.
Claim Objections
1. Claims 6, 12 and 20 are objected to because of the following informalities: There is a typo in the formula in claims 6, 12 and 20. Na7Al6Si6O24S3 should correctly be “Na7Al6Si6O24S3”. 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.
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.
2. Claims 1-20 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.
The term “high temperature” in claims 1, 7 and 13 is a relative term which renders the claim indefinite. The term “high temperature” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, claims 1, 7 and 13 are indefinite. Claims 2-6, 8-12 and 14-20 depend from claims 1, 7 or 13 and are indefinite for the same reasons. For examination, a polymer or polymer blend including any of polysulfone, polyether sulfone and polyphenylene sulfone will be interpreted as meeting the limitation of a high temperature polymer.
The term “deep blue color” in claims 4, 5, 10, 11, 18 and 19 is a relative term which renders the claim indefinite. The term “deep blue color” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, claims 4, 5, 10, 11, 18 and 19 are indefinite. Claims 6, 12 and 20 depend from claim 5, 11 or 19 and are indefinite for the same reasons. For examination purposes, any complex sodium silicate including sulfur and aluminum will be interpreted as reading upon a “deep blue color” pigment.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
3. Claim(s) 1, 2, 7, 8 and 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tadros et al. (U.S. PGPUB No. 2005/0100853).
I. Regarding claims 1 and 2, Tadros teaches a dental aligner (abstract) comprising: a monolayer of a polymer (0067), selected from a group including polysulfone (0022, and which as noted above is considered a clear-high temperature polymer). Tadros further teaches the monolayer having a thickness of 5-50 mils (0067). Additionally, Tadros teaches that the polymer of the monolayer may include pigments and dyes (0074). Tadros fails to specifically teach an example dental aligner using polysulfone and having thickness of 15-30 mils and inclusion of bluing dye agents in an amount as claimed.
First, Tadros does teach that the thickness of the monolayer of the dental aligner can be 5-50 mils, which overlaps with the claimed range. Furthermore, overlapping ranges are prima facie evidence of obviousness.
Second, Tadros fails to provide an example where the polymer is polysulfone. However, Tadros makes clear that polysulfone can be used as an alternative (0022). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute polysulfone for the polymers used in Tadros’ exemplary dental aligners. One would have been motivated to make this modification as one could have made this substitution with a reasonable expectation of success, particularly given that Tadros teaches that any of their disclosed polymers can serve as alternatives for a polymer in a dental aligner (see above), and the predictable result of providing a polymeric dental aligner.
Third, Tadros does teach that a dye or pigment may be included (0074). Additionally, the selection of the color of the dye or pigment is simply an aesthetic design choice. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to select a blue colored pigment/dye to provide a blue appearance to the dental aligner. Furthermore, aesthetic design changes have been held as prima facie obvious. In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947) (Claim was directed to an advertising display device comprising a bottle and a hollow member in the shape of a human figure from the waist up which was adapted to fit over and cover the neck of the bottle, wherein the hollow member and the bottle together give the impression of a human body. Appellant argued that certain limitations in the upper part of the body, including the arrangement of the arms, were not taught by the prior art. The court found that matters relating to ornamentation only which have no mechanical function cannot be relied upon to patentably distinguish the claimed invention from the prior art.).
Finally, Tadros fails to teach the amount of bluing dye agent. However, the amount of the dye/pigment will alter the appearance and final color of the dental aligner. Therefore, it would have been obvious to one of ordinary skill in the art to optimize to the claimed range for amount of pigment/dye to yield a desirable aesthetic appearance to the dental aligner.
II. Regarding claims 7 and 13, Tadros teaches a dental aligner (abstract) comprising: a monolayer of a polymer (0067), selected from a group including polysulfone (0022, and which as noted above is considered a clear-high temperature polymer). Tadros further teaches the monolayer having a thickness of 5-50 mils (0067). Additionally, Tadros teaches that the polymer of the monolayer may include pigments and dyes (0074). Tadros fails to specifically teach an example dental aligner using polysulfone and having thickness of 15-30 mils.
First, Tadros does teach that the thickness of the dental aligner can be 5-50 mils, which overlaps with the claimed range. Furthermore, overlapping ranges are prima facie evidence of obviousness.
Second, Tadros fails to provide an example where the polymer is polysulfone. However, Tadros makes clear that polysulfone can be used as an alternative (0022). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute polysulfone for the polymers used in Tadros’ exemplary dental aligners. One would have been motivated to make this modification as one could have made this substitution with a reasonable expectation of success, particularly given that Tadros teaches that any of their disclosed polymers can serve as alternatives for a polymer in a dental aligner (see above), and the predictable result of providing a polymeric dental aligner.
III. Regarding claims 8 and 14-16, Tadros makes obvious claims 7 and 13 (see above), including the polymer being polysulfone (see above), but fails to teach the inclusion of 0.05-2 wt% of a bluing dye agent.
First, Tadros does teach that a dye or pigment may be included (0074). Additionally, the selection of the color of the dye or pigment is simply an aesthetic design choice. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to select a blue colored pigment/dye to provide a blue appearance to the dental aligner. Furthermore, aesthetic design changes have been held as prima facie obvious. In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947) (Claim was directed to an advertising display device comprising a bottle and a hollow member in the shape of a human figure from the waist up which was adapted to fit over and cover the neck of the bottle, wherein the hollow member and the bottle together give the impression of a human body. Appellant argued that certain limitations in the upper part of the body, including the arrangement of the arms, were not taught by the prior art. The court found that matters relating to ornamentation only which have no mechanical function cannot be relied upon to patentably distinguish the claimed invention from the prior art.).
Second, Tadros fails to teach the amount of bluing dye agent. However, the amount of the dye/pigment will alter the appearance and final color of the dental aligner. Therefore, it would have been obvious to one of ordinary skill in the art to optimize to the claimed range for amount of pigment/dye to yield a desirable aesthetic appearance to the dental aligner.
4. Claim(s) 3-6, 9-12 and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tadros in view of Sensient Cosmetic Technologies (“Cosmetic Pigments”).
Regarding claims 3-6, 9-12 and 17-20, Tadros makes obvious claims 2, 8 and 16 (see above), but fails to teach the inclusion of the specific ultramarine deep blue pigment having the formula as claimed.
However, Sensient Cosmetic Technologies teaches that ultramarine deep-blue pigments having the formula Na7Al6Si6O24S3 are commercially known pigments for use in cosmetics (page 9). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute Sensient’s particular ultramarine blue pigment for the generic pigment of Tadros. One would have been motivated to make this modification as Sensient teaches that their pigments exhibit superior chroma and dispersibility, as well as being global compliant and able to be produced with superior batch to batch consistency (page 2).
Conclusion
Claims 1-20 are pending.
Claims 1-20 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S WALTERS JR whose telephone number is (571)270-5351. The examiner can normally be reached Monday-Friday 8-5.
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/ROBERT S WALTERS JR/
January 19, 2026Primary Examiner, Art Unit 1717