DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Interpretation
The pending claims are product-by-process claims. Accordingly, they are interpreted using the provisions of MPEP 2113.
MPEP 2113 provides that product-by-process claims are not limited by the recited steps, but are only limited by the structure implied by the recited steps (emphasis added). Therefore, products made by different processes can also meet the claim when they appear to be structurally identical to the claimed product. Also, product claims do not depend upon the process upon which they are produced as the patentability of a product is not determined by how it is made.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim(s) 2-21 are rejected under pre-AIA 35 U.S.C. 102 (a)(1) as anticipated by or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Simkins (US Patent No. 7,092,784).
Regarding claim 2, Simkins discloses an orthodontic appliance (“appliance 111” – 4:55-4:58) made by a thermal forming process (1:37-1:45; 8:1-8:19) and disposing the heated material over a mold (“die”) to form an orthodontic appliance (5:61-6:18). Simkins further discloses (4:55-4:58) that the material used is 0.03 inches thick, which falls within the claimed range of “0.01-0.14 inches” as now required in the claim, thus meeting the claim.
The other portions of the claim are not limiting as they are directed to the steps of production, which are not considered limiting, except as to the structure implied by the recited steps. Since there is a thermoforming process conducted in accordance with both the Simkins reference and in the claim with the same type of material having a similar thickness, one of ordinary skill in the art, at the time the invention was made, would have reasoned that the structures of the products produced by the Simkins reference would have been the same as those produced in the claim, based on the current evidence of record.
Regarding claims 3-16 and 21, these limitations are all process limitations that do not impart a different structure to the resulting product than is described in claim 2 above.
The term “thermoforming” implies that the material is heated and this is met in claim 2 above – but since product claims do not depend upon the process upon which they are produced, the particular control/mode of heating would not seem to change the resulting product’s structure. Also, anything limiting the mold being used would not seem to limit the product formed by the mold. Accordingly, these claims would be considered met by the same disclosure, as in claim 2 above.
Regarding claim 17, Simkins discloses the subject matter of claim 2, and further discloses that the orthodontic appliance is an aligner (as shown in Fig. 2C).
Regarding claim 18, Simkins discloses the subject matter of claim 2, and further discloses that the appliance includes a polymeric shell (4:45) having tooth-receiving cavities (as shown in Fig. 2C) shaped to reposition a patient’s teeth.
Regarding claims 19-20, Simkins discloses the subject matter of claim 2, the final appliance would be “cut” or “trimmed” to size as formed after molding as it would have edges that are of the correct size as to fit in a patient’s mouth. The claim does not positively require trimming or cutting as there would not be an apparent difference in the final structure of an object that is cut or trimmed and one that is not cut or trimmed, when they are the same size.
Response to Arguments
Applicant’s arguments with respect to all claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 ANDREW D GRAHAM whose telephone number is (469)295-9232. The examiner can normally be reached Monday - Friday 7:30AM-4:00PM (CST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christina Johnson can be reached at (571) 272-1176. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANDREW D GRAHAM/Primary Examiner, Art Unit 1742
Prosecution Insights