Status under America Invents Act
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Rejections based on Prior Art
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 9, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hickham (US 5,037,298).
In regard to claim 1, Hickham discloses an intra-oral appliance having an internal member (Figure 5) comprising a tongue crib 26 defining an interior space for receiving a patient’s tongue; first and second poseable arms 16, 18 connected to the back end of the crib 22 wherein the first and second arms 16, 18 are moveable/poseable to position the tongue crib 26; and wherein the first and second arms 16, 18 comprise tubing (column 4, lines 42-43, indicate that the identified arms 16 (“saliva ejectors”) include “saliva tubes” 32). In regard to claims 9 and 10, note the channel at the back of the crib 22 formed between 33 and 24 for receiving tubing 28.
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, 2, 6, 7, 9, 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 2004/0101804) in view of Hickham (US 5,037,298).
In regard to claim 1, Anderson discloses an internal member for an intra oral appliance comprised of a tongue crib 33 having an interior space sized to accept tongue 12 with an opening at the back end. The Anderson device further includes poseable first and second arms 20 comprised of tubing connected to the back end of the tongue crib 33 and allow for the tongue crib 33 to be moved into and held in a desired position. In regard to the limitation that the “tongue crib” define an “interior space sized to accept a tongue and enclose at least an anterior tip of the tongue of the patient” the tongue crib 33 of Anderson is open and arguably does not enclose the patient’s tongue. It is well known in the prior art, however, to provide tongue shields/cribs such as that disclosed by Anderson with an enclosed space for the tip of the tongue as evidenced for example by Hickham who teaches the addition of tongue guides 26 (note e.g. Figure 18) that extend between sides of the tongue shield plates 24 to form an enclosed space for the tip of the patient’s tongue (note column 4, lines 3-18). To have provided the Anderson tongue shield/crib plates 33 with tongue guides like those provided by Hickham at 26 in order to form an enclosed space for the tip of the patient’s tongue would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
In regard to claim 2, Anderson indicates that a compliant ductile wire may be embedded in the wall of the tubes/arms 20 in order to allow the tubes/arms 20 to retain their bent shape (note paragraph [0050]). In regard to claims 6 and 7, note apertures 24 in tubing 20. In regard to claim 9, the arms/tubes 20 include a channel capable of receiving tubing.
In regard to claim 15, Anderson discloses an internal member having a tongue crib and poseable first and second arms as explained above, but lacks the claimed external frame with first and second lip retractors, retractor flanges, wing members and flexible resilient member as required. Hickman, however, teaches that it is desirable to provide such first and second lip retractors 20, having first and second flanges 48, first and second wing members 50 and flexible resilient member 56 in order to keep the patient’s mouth open and provide access to the dental work site. To have provided the Anderson oral appliance with first and second lip retractors (and associated flanges, wings and resilient biasing member) as taught by Hickham in order to keep the patient’s mouth open while providing access to the dental work site would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. In regard to claim 16, Anderson indicates that a compliant ductile wire may be embedded in the wall of the tubes/arms 20 in order to allow the tubes/arms 20 to retain their bent shape (note paragraph [0050]).
Claim 11, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Hickham (US 5,037,298) in view of Cohen et al (US 4,019,255)
In regard to claim 11, Hickham discloses an intra-oral appliance having an external member with first and second arcuate shaped lip retractors 20 having inner and outer surfaces, and a semi-circular open channel for receiving a patient’s lips. The first and second lip retractors 20 each having a retractor flange 48 and a wing member 50 that extends backwards from the lip retractors. The Hickham device further includes a flexible member 56 connected with the first and second retractor flanges 48 for biasing the first and second lip retractors 20. In regard to the limitations requiring first and second connectors attachable to the first and second arms wherein the first connector has an aperture passing through the first retractor flange and the second connector having an aperture passing through the second connector flange, the limitations appear to be directed to applicant’s embodiment of Figure 17 where paragraph [0044] of the specification describes “first and second connectors 339, 371 having apertures 340, 360 passing through the retractor flanges 311, 321” (numeral “371” should apparently be 359) through which the suction tubing is passed. In Hickham the suction tubing 36 is passed around the edge of the lip retractors. It is known, however, in the prior art to provide apertures (“connectors”) through the wall/flange areas of lip retractors as taught by Cohen et al (note Figures 1, 2; column 3, lines 24-30) in order to retain the retractor suction tubing. To have formed apertures in the Hickham lip retractor walls/flange as taught by Cohen et al in order to retain the suction tubing would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
In regard to claim 13, Hickham in Figure 14 teaches forming a channel at 304 of the wing members 310 “to assist in keeping the saliva suction hoses 36-36 away from the area of work” (column 6, lines 37-40). In regard to claim 14, the identified wing members 50 of Hickman are aligned.
Double Patenting Rejections
Statutory Double Patenting -
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 3, 4, 5, 17, and 18 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1, 2, 3, 9, and 11 respectively, of prior U.S. Patent No. 12,171,631. This is a statutory double patenting rejection.
Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2 and 6-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,171,631. Although the claims at issue are not identical, they are not patentably distinct from each other because each of the limitations of the currently pending claims are set forth in the patented claims of ‘631.
For example, with respect to pending claim 1, patented claim 1 of ‘631 sets forth each of the claimed elements – the tongue crib, and poseable first arm and second arms allowing for the tongue crib to be moved into and held in position and wherein the arms comprise tubing. Pending claim 1 sets forth no patentable distinctions from that previously claimed in applicant’s earlier patent. Likewise, the poseable wire subject matter of pending claim 2 is set forth in previously patented claim 1. Likewise, the subject matter of pending claims 5, 6, 7, 8, 9, 10, 11, 12, 15, and 16 is set forth in patented claims 3, 4, 5, 6, 7, 8, 9, 11, 9, and 10, respectively.
In regard to claims pending claims 13 and 14, it would have been obvious to one of ordinary skill in the art to have provided the previously claimed first and second wing members (patented claim 9) with channels in order to secure the first and second poseable arms and to have aligned the wings with the lip retractors (patented claim 9) in order to provide for a functional device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ralph Lewis whose telephone number is (571)272-4712. The examiner can normally be reached Monday-Friday from 9AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Edelmira Bosques 571 270-5614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RALPH A LEWIS/Primary Examiner, Art Unit 3772 (571) 272-4712