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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/21/26 has been entered.
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 21, 22, 24-28, 30, 31, 33, 34, 36, 37, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Dukesherer (US Pub 2005/0085715 -cited by applicant) in view of Hynes et al (US Pub 20110092803 -cited by applicant).
Re claim 21, 22, 24-28, 33, 34, 36, 37, 39: Dukesherer discloses a tracking device for insertion into an oral cavity comprising:
an electromagnetic sensor [0078; see the EM sensor 90]; and
a sensor housing having a first surface within the oral cavity, and a second surface and a third surface each sized and shaped to engage against spaced apart teeth profile in the oral cavity, the housing configured to receive the sensor [0068, 0078, 0092, figure 4; see dynamic reference frame 70 with recess 78 for a sensor bobbin 90 wherein the frame is configured as a bite block fitted in the oral cavity]; and
wherein the electromagnetic sensor coupled to the flexible sensor housing so as to be positioned within the oral cavity and in a housing cavity between opposed surfaces to overmold the sensor within the housing (Fig 4; wherein the sensor is positioned in recess 78 such that it is coupled thereto).
Dukesherer discloses all features except that the housing has a first 3D convex shape sized and shaped to engage the palate including a fourth planar surface opposite the convex surface, where the second and third surfaces are configured to flex to force the first edge and the second edge against spaced apart teeth within the oral cavity to assist in retaining the sensor housing within the oral cavity. However, Hynes teaches of a non invasive dental device for navigation including a bite block that is an impression of maxillary teeth and upper palate [0026, 0027; see the thermo-moldable impression whereby the impression of the palate forms a first 3D convex surface and opposed concave/planar surface; further, the impression is of both the upper teeth and palate and this indicates that the material is flexed to force a first and second edge against spaced apart teeth to assist in retention]. It would have been obvious to the skilled artisan to modify Dukesherer, to use the particular bite block as taught by Hynes as the dynamic reference frame, as such is a well-known bite block that accurately fixes the frame to the anatomy and which results in the sensor being coupled to the planar portion.
Re claim 30: Dukesherer discloses that the sensor is wireless [0100; see the wireless sensor].
Re claims 31: Dukesherer discloses a first and second adhesive portion at the second and third surfaces to adhere the housing to the teeth [0069; see the adhesive in the adhesive recess that couples the frame 70 to the recess and to the patient] and an adhesive coupling the first surface to a teeth profile in the oral cavity [0069; see the adhesive in the adhesive recess that couples the frame 70 to the recess and is capable of coupling to teeth].
Claims 23 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Dukesherer/Hynes, as applied to claims 22 and 34, in view of Bashyam (US Pub 2014/0135868 -cited by applicant).
Re claims 23, 35: Dukesherer/Hynes disclose all features except that a biocompatible material is within the sensor cavity. However, Bashyam teaches of an intraoral device wherein hardware and sensors are within housing covered with biocompatible material [0054; see the biocompatible material]. It would have been obvious to the skilled artisan to modify Dukesherer/Hynes, to use a material as taught by Bashyam, in order to permit the device to feel smooth and comfortable in the mouth [0054].
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Dukesherer/Hynes, as applied to claim 27, in view of Choi et al (US Pub 2014/0343395 –cited by applicant) and Novak (US Pub 20120256750 -cited by applicant).
Re claim 32: Dukesherer/Hynes disclose all features except that the housing is 3D printed and formed of polyactic acid. However, Choi discloses the sensor housing is three-dimensionally printed from a negative print in response to a CT scan of the oral cavity of a patient [0035, 0036; see the 3D printing based on a CT scan]. Further, Novak teaches of a sensor with housing form of PLA [0072; see the housing material]. It would have been obvious to the skilled artisan to modify Dukesherer/Hynes, to use a 3D printing as taught by Choi formed of polyactid aicd as taught by Novak, as such is a well-known way to fabricate the structure for accurate positioning in the patient and because the acid is a well known material for a sensor housing that such could be configured via simple substitution.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Dukesherer/Hynes, as applied to claim 27, in view of Choi et al (US Pub 2014/0343395 –cited by applicant).
Re claim 38: Dukesherer/Hynes disclose all features except that the housing is molded from a negative print in response to an image scan. However, Choi discloses the sensor housing is three-dimensionally printed from a negative print in response to a CT scan of the oral cavity of a patient [0035, 0036; see the 3D printing based on a CT scan]. It would have been obvious to the skilled artisan to modify Dukesherer/Hynes, to use a 3D printing as taught by Choi, as such is a well-known way to fabricate the structure for accurate positioning in the patient.
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 21-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-39 of U.S. Patent No. 11,547,491. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘491 features a patient tracking device for insertion into the oral cavity including a sensor housing with a 3D convex surface to engage the palate and spaced apart teeth and an electromagnetic sensor carried by the sensor. Further, ‘491 features a biocompatible material in the cavity, a planar fourth surface, surfaces configured to force to flex, a wireless sensor, and adhesive portions. Therefore, the skilled artisan would conclude that the instant claims are an obvious variant.
Response to Arguments
Applicant's arguments filed 1/21/26 have been fully considered but they are not persuasive. Applicant argues that the skilled artisan would not combine Dukesherer with Hynes to arrive at the claimed invention because such a combination would only occur after the Hynes array has been cured/solidified, such that it would be able to provide a structure capable of supporting the EM sensor. Respectfully, the Examiner disagrees. The claims are directed to an apparatus that is “sized” to engage a palate and against spaced apart teeth. Dukesherer discloses a housing for a sensor wherein the housing may be configured as a dental impression [see 0092]. Dukesherer meets the limitations of the housing with surfaces at least sized to engage spaced apart teeth, wherein the housing receives the EM sensor. Dukesherer does not disclose the particular features of the dental configuration and, therefore, does not disclose that the dental impression has a convex surface sized to engage the palate. Hynes teaches of a dental impression that includes a portion that presses against the teeth as well as a portion engaging the palate. The combination results in the dental impression as set forth in Dukesherer that also includes a convex section that extends along the palate. The combination would not only occur after the Hynes array has cured. Rather, the moldable housing (the resulting combination has a housing that includes portions that engage the teeth and the palate) is flexible such that is can be formed to fit a specific patient, as is typically done. While the sensor may be placed into the sensor housing after the housing has cured, the claim does not require this. The claim requires that the flexible sensor housing be configured to receive the sensor. First, a sensor can be physically placed within a sensor cavity of the housing (i.e. see Dukesherer’s figure 4) before it is cured, thereby meeting the limitation. In addition, it appears that even if the sensor could only be placed within the cavity after curing, the limitation would still be met as the housing is a “flexible” housing because it had previously been molded and could be molded again. It is noted that parent 16/401,456 is a similar structure but included additional limitations of a first and second edge the flexed to force between the spaced apart teeth to retain the housing within the oral cavity.
The prior specification and claim objections are withdrawn due to amendments. The double patenting rejection is held in abeyance.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL T ROZANSKI whose telephone number is (571)272-1648. The examiner can normally be reached Mon - Fri 8:00-4:00.
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/MICHAEL T ROZANSKI/Primary Examiner, Art Unit 3797