DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. The amendment filed on December 1, 2025 has been entered in the above-identified application. Claims 1-3, 5, and 7 are amended. Claims 1-15 are pending and under consideration.
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.
3. Claims 1-15 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.
The term “softer material” is a relative term which renders the claim indefinite. The term “softer material” 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.
Claim 7 recites that “the mesh structure of the mat portion has a regular pattern or an irregular pattern, or the mesh structure of the mat portion is formed as a result of repetition of sparse and dense structures.” The term “sparse and dense” is a relative term which renders the claim indefinite. The term “sparse and dense” 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.
Appropriate correction or clarification is required.
Claim Rejections - 35 USC § 103
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.
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.
4. Claims 1, 2, 4, and 6-15 are rejected under 35 U.S.C. 103 as being unpatentable over Brennan et al. (US 2005/0136370 A1).
Brennan et al. disclose multi-layer adhesives and methods that are useful for bonding orthodontic appliances to a tooth structure. The multi-layer adhesives can be precoated on an orthodontic appliance. In one embodiment, Brennan et al. teaches a packaged article. The packaged article includes: an orthodontic appliance (meeting the limitations of claim 15) having a base (equivalent to the first sheet layer of the claimed invention) for bonding the appliance to a tooth structure; a first hardenable adhesive layer and a second hardenable adhesive layer (equivalent to the intermediate sheet layer of the claimed invention), each extending across at least a portion of the base of the appliance. Each of the adhesive layers may independently be patterned or non-patterned. Each of the adhesive layers may independently include, for example, light cure or chemical cure adhesives. Optionally, one or more additional hardenable adhesive layers, which may be in contact with a release substrate (equivalent to the second sheet layer of the claimed invention), extend across at least a portion of the first or second layers. The multi-layer adhesive 20 illustrated in FIGS. 1 and 2 includes adhesive layer 22 extending across base 12, and adhesive layer 24 extending across base 12 and adhesive layer 22. The multi-layer adhesive 20 can include additional layers that are not illustrated in FIGS. 1 and 2. Layers 22 and 24 are layers of different adhesives that may or may not cover the same area. Layers 22 and 24 may independently be discontinuous (e.g., a patterned layer) or continuous (e.g., non-patterned) material extending across all or a portion of another material (thus creating a mat portion being formed so as to have a mesh structure and a binding portion as recited in claim 1). Adhesive layers 22 and 24 may differ in properties including, for example, chemical composition; viscosity; hydrophilicity, thickness; curing times; curing mechanisms; color; change in color upon curing; enzyme release; fluoride release; bond strengths upon curing; filler loading; and filler types. Each layer of the multi-layer adhesive can be patterned or non-patterned. The layers can cover the same or different areas of the appliance or adhesive delivery system. One layer can cover none of, partially cover, or fully cover another adhesive layer. Patterned layers may be in forms including, for example, lines, dots, squares, circles, and combinations thereof. Layers can be of uniform or varying thickness. Such the multi-layer adhesives offer benefits such as increased bonding efficiency and/or a decreased number of bonding steps. Preferably, the bond strength is increased, thereby reducing the incidence of bond failures. (see Abstract and paragraphs 0008, 0036, 0037, 0038, 0039, 0041, 0045, 0046, 0049, 0051, 0056, 0062).
With regards to the limitations that the mat portion is of a softer material than each of the first sheet layer and the second sheet layer, the first sheet layer and the second sheet layer are made of the same material or different materials, the thickness of each layer, the pattern and symmetry of the mesh structure, the repetition of the mesh structure, the proportion of the binding portion to the mat portion is 30 to 70%, the number of layers (i.e., an additional layer such as the buffer coating layer) and the flexural strength of the layers, the Examiner would like to point out that workable physical properties are deemed to be obvious routine optimizations to one of ordinary skill in the art, motivated by the desire to obtain the required properties, particularly given that Brennan et al. specifically state that the disclosed adhesive layers may differ in properties including, for example, chemical composition; viscosity; hydrophilicity, thickness; curing times; curing mechanisms; color; change in color upon curing; enzyme release; fluoride release; bond strengths upon curing; filler loading; and filler types. With regards to the process limitations of claims 12 and 14, the patentability of a product does not depend on its method of production. If the product is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.
5. Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Brennan et al. (US 2005/0136370 A1) in view of Warunek et al. (US 5112640 A).
Brennan et al., as discussed above, do not teach that the base or release layer is at least one selected from among glycol modified polyethylene terephthalate (PETG), polyester, co-polyester, polypropylene, polyethylene, acrylic, polyetheretherketone, polyamide, polyethylene terephthalate, polybutylene terephthalate, polyetherimide, polyethersulfone, polytrimethylene terephthalate, or thermoplastic polyurethane or that the adhesive layer is selected from among silicone rubber, elastomeric alloy, thermoplastic elastomer (TPE), thermoplastic vulcanizate (TPV) elastomer, polyolefin blend elastomer, thermoplastic co-polyester elastomer, thermoplastic polyamide elastomer, thermoplastic polyurethane (TPU), elastomeric alloy, thermoplastic elastomer (TPE), thermoplastic vulcanizate (TPV) elastomer, thermoplastic co-polyester elastomer, or polyester elastomer.
However, Warunek et al. disclose a dental prosthetic materials using organopolysiloxane elastomers comprising copolymers of dimethyl and methylvinyl siloxanes such that the elastomers are effectively bonded to polymeric and metallic substrates as denture liners, obturators, maxillofacial prosthetic devices and appliances with a group of trifunctional silane coupling agents. The dental appliances having permanent silicone elastomers bonded thereto forming composite structures with enhanced strength, dimensional stability and elasticity and for preventing and treating chronic tissue irritation from hard dental polymers and for cushioning soft tissues; liners after oral surgery, maxillofacial prosthetic devices, like obturators for defects in the palate, and the like. The composite-like structure is formed by applying a film of a coupling agent to the appliance, the coupling agent comprising a silane, drying the silane film on the appliance; applying to the dried silane film on said appliance a silicone elastomer to form the composite-like structure, and curing the composite structure. Suitable substrates for the composite-like structures comprise materials commonly used in fabricating prosthodontic appliances, such as acrylics, polyesters, polyurethanes and other resinous materials, as well as certain metals, like stainless steel, aluminum, cobalt and chrome. Some of the most widely used hard materials in dentistry are the denture base resins which can also be used in forming the composites. They include the acrylics, such as poly(methyl methacrylate) (PMMA), rubber modified acrylics, vinyl acrylic copolymers, hydrophilic acrylics, fluid acrylics, and so on. Other useful denture base materials are the glycol-modified poly(ethylene terephthalates).
Accordingly, it would have been obvious to one having ordinary skill in the art to use glycol-modified poly(ethylene terephthalates) as the base or release layer and silicone elastomers as the adhesive layer in the orthodontic appliance taught by Brennan et al., given that Warunek et al. specifically teach that such composite structures have enhanced strength, dimensional stability and elasticity and can be used by maxillofacial prosthetic devices.
Response to Arguments
6. Applicant's arguments filed on December 1, 2025 have been fully considered but they are not persuasive.
With regards to the rejection of claims 1-15 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, Applicant’s submit that the term "softer" per se is a relative term; however, in claim 1 provides a definite reference as the third material is relatively softer with respect to each of the first and second materials. Similarly, the Applicants argue that the term "sparse and dense" is a not indefinite given that the second structure is denser than the first structure, which provides a clear reference between the densities of the first and second structures.
However, the Examiner disagrees. In this case, the Specification does not provide examples or teachings that can be used to measure a degree even without a precise numerical measurement (e.g., a figure that provides a standard for measuring the meaning of the term of degree) and the Applicants have not provided evidence that the meaning of the term of degree can be ascertained by one of ordinary skill in the art when reading the disclosure. Even if the Specification uses the same term of degree as in the claim, a rejection is proper if the scope of the term is not understood when read in light of the specification.
With regards to the rejection of claims 1, 2, 4, and 6-15 are rejected under 35 U.S.C. 103 as being unpatentable over Brennan et al. (US 2005/0136370 A1) and the rejection of claims 3 and 5 under 35 U.S.C. 103 as being unpatentable over Brennan et al. (US 2005/0136370 A1) in view of Warunek et al. (US 5112640 A), the Applicants state that Brennan's multi-layer structure consists solely of coated adhesive films applied to an orthodontic bracket base, not a composite sheet structure as claimed. Applicants argue that in Brennan, the "intermediate and outer layers" are adhesive coatings, not structural sheets, the "packaged article" involves adhesive layers disposed on the appliance and not a composite material sheet used to form orthodontic appliances or retainers and hence it is the Applicants position that the cited reference teaches a bonding medium (adhesive system), not a laminated structural composite sheet as recited in the claims. Applicants further state that Brennan's "patterned" layers merely refer to surface patterns of adhesive coverage (e.g., dots, lines, grids) and not a three-dimensional mesh structure or a porous mat. Applicants state that the cited reference nowhere teaches a fibrous or open-mesh intermediate layer that permits penetration of adjacent materials. Furthermore, Applicants argue that the claimed configuration yields unexpected results relative to the adhesive laminates of Brennan that include enhanced flexibility and comfort from the soft, mesh-structured interlayer.
First, with regards to the arguments that the applied art fails to teach a composite material sheet, the Examiner would like to point out that the structure taught by Brennan et al. does in fact meet to the limitations of a composite (i.e., a structure made of distinct layers). Second, with regards to the argument that Brennan does not teach a three-dimensional mesh structure or a porous mat or a fibrous or open-mesh intermediate layer thus creating a mechanically bonded structure, it is noted that the features upon which applicant relies (i.e., three-dimensional mesh structure, porous mat, or a fibrous or open-mesh intermediate layer thus creating a mechanically bonded structure) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Lastly, as to the assertion of unexpected results, a showing of unexpected results must be based on evidence, not argument or speculation. The specification presents no factual evidence to show that results were actually unexpected in comparison to the results in the prior art.
Conclusion
7. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHEEBA AHMED whose telephone number is (571)272-1504. The examiner can normally be reached Monday-Thursday 7am-6pm.
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/SHEEBA AHMED/Primary Examiner, Art Unit 1787