DETAILED ACTION
Response to Amendment
Applicant’s amendments filed 4/21/26 have been entered. Currently claims 1-14, 16-21, and 26-30 are pending, claims 12-14, 16-21 are withdrawn and claims 15, 22-25 are cancelled.
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 1-11, 26-30 are rejected under 35 U.S.C. 103 as being unpatentable over Connell et al (US Patent 20210177549).
As to claims 1 and 30, Connell discloses a medical article having a microstructured surface (abs). The base member can be planar or non-planar having a curved surface (paragraph 117). The base member can be made of a single polymeric material (paragraph 101). The base member can be made of thermoplastic polymers (paragraph 100). The microstructured surface can be formed by a variety of microreplication methods, such as thermoforming the base member (paragraph 31) which includes including embossing a thermoplastic film against a tool having a microstructured pattern, coating a fluid onto a tool having a microstructured pattern and solidifying the fluid (paragraph 36), The microstructured article comprises peaks having side walls with angles greater than 10 degrees (paragraph 51) and valleys have a maximum width from 10 to 250 microns (paragraph 20). However, this reference is silent to the polymer shape having a curvature radius of up to 20mm.
It would have been obvious to one of ordinary skill in the art to have modified Connell and made the article have a curved shape with a curvature radius of up to 20mm as they the article of Connell is used for the same purposes as the present invention as a dental device and would of ordinary skill in the art would know how to adjust the curvature of the article depending upon the end use of the article and less that 20mm would be suitable to retainers or other dental articles.
It should be noted that claims 1 and 30 are a product by process claim in that it defines how the article was formed. For purposes of examination, product-by-process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. See MPEP 2113. In the present case, the recited steps imply the same structure, and the reference discloses such a product.
Since the reference discloses embossing and forming the microstructured article on the tool the article will be considered to be integrally formed on the curved portion as a single piece.
As to claims 2, 9 and 10, Connell discloses that the microstructure surface is integral to the curvature as these can be used as mouthguard and other dental articles (paragraph 7).
As to claims 3-5, Connell discloses that the thermoplastic polymers can be polyamides, styrenic copolymers, polyolefins (paragraph 100). These are the same polymers used within the present invention for the same purposes and therefore would inherently have a draw down ratio of greater than 1.1 and elongation at break of 50 to 100% or greater. In the alternative would have been obvious to use a thermoplastic polymer of these materials with that ratio and elongation break.
As to claims 6 and 7, Connell discloses that the surface can be curved and can have microstructures, however is silent to the polymer having a second curve with or without microstructures. It would have been obvious to one of ordinary skill in the art to have formed the article to have a second curve with or without microstructures as it would be a design choice of the user depending upon the final use of the article as one of ordinary skill in the art would know how to adjust the shape of the article depending upon the desired end use of the article as there intended for the same purpose as the invention.
As to claim 8, Connell discloses that the height of the peaks of the microstructured article can be from 10 to 125 microns (paragraph 63).
As to claim 11, Connell discloses that the articles are used in dental and orthodontic articles and therefore one of ordinary skill in the art would know how to adjust the coefficient of friction depending upon the desired end structure of the teeth and one would know how to control this adjustment.
As to claims 26 and 27, Connell discloses a base member wherein the thickness can be lower in certain areas (paragraph 106), and the article including the microstructure can be patterned by the tool (paragraph 36).
As to claim 28, and 29, Connell discloses that the microstructured article can include flat surface areas relative to the base member and therefore would have an area that the microstructure region is absent in. Further the microstructured article is substantially free of intersecting side walls or other obstructions to the valleys.
Response to Arguments
Applicant's arguments filed 4/21/26 have been fully considered but they are not persuasive.
Applicant’s argue that the applied reference does not disclose the microstructured surface being integrally formed on the curved portion by a single thermoplastic sheet. The examiner respectfully disagrees and argues that Connell discloses multiple methods of forming the microstructured article. In at least two methods the article is formed of a single film layer over a tool as seen in paragraph 36. Since coating of a fluid onto a tool having a microstructured pattern, solidifying the fluid, and removing the resulting film would form a single layer and passing a thermoplastic film through a nip roll to compress against a tool having a microstructured pattern (embossing) would also form of a single piece of thermoplastic polymer. Further its noted that these claims are directed to product by process and the implied structure is the same as the prior art.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER M POLLEY whose telephone number is (571)270-5734. The examiner can normally be reached Monday through Friday from 8am till 4:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mark Ruthkosky can be reached at 5712721291. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER M POLLEY/Primary Examiner, Art Unit 1785
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