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 .
Prosecution History Summary
Claims 1 and 13 are amended.
Claims 1-20 are pending.
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.
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Claims 1-2, 9, 11, and 13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, and 17-18 of U.S. Patent No. 11,966,366. Although the claims at issue are not identical, they are not patentably distinct from each other because both inventions are directed towards a clinical data file with data fields and indicator for enabling security of that field being accessed by a passcode.
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.
Claims 1-2 and 4-19 are rejected under 35 U.S.C. 103 as being unpatentable over Uemura (U.S. Publication No. 2008/0013727) in view of Onishi et al. (JP 2004/289456A).
As per claim 1, Uemura teaches a clinical data file for securing medical information, comprising:
-medical information arranged in corresponding data fields, the medical information comprising one or more of: treatment professional information, patient personal information, and one or more patient images (Uemura: figure 3; address, photo, and medical history),
-wherein a viewable portion of the medical information in a corresponding at least one data field is viewable by a third party and a securable portion of the medical information is securable to hide the securable portion of the medical information from being viewable from the third party (Uemura: para. 38; para. 91-92; para. 95; Providing the original document that was scanned with data fields and the user selecting fields and setting confidential level, encryption degree. Based on the user login and password, determine the authentication level of the document for that user and display those regions.).
Uemura does not explicitly teach the following, however, Onishi teaches the following: wherein the securable portion of the medical information, including at least part of the one or more patient images, is covered by one or more layers to hide the securable portion of the medical information from the third party (Onishi: para. 16-18; para. 22; para. 28; Concealment unit encrypts part of the image data in an image layer. Output is superimposed layers.), wherein the one or more layers is removable to expose the securable portion of the medical information by the third party entering a pass code (Onishi: para. 39-40; Provide password input to show viewing rights.).
One of ordinary skill in the art would have recognized that applying the known technique of Warner would have yielded predictable results and resulted in an improved system. It would have been recognized that applying the technique of Onishi to the teachings of Uemura would have yielded predictable results because the level of ordinary skill in the art demonstrated by the references applied shows the ability to incorporate such features into similar systems. Further, applying layers of password protected sections to Uemura teaching document scanning in a format with medical fields would have been recognized by those of ordinary skill in the art as resulting in an improved system that would provide a system that provided privacy of personal medical information (Onishi: para. 4).
As per claim 2, the data file of claim 1 is as described. Uemura teaches wherein the clinical data file is in a single format (Uemura: para. 77).
As per claim 4, the data file of claim 1 is as described. Uemura teaches wherein the one or more layers that are saved separately from the one or more patient images (Uemura: para. 46-47; para. 49; The original document is provided in accordance to the encryption and confidential settings but those settings are removed based on user access.).
As per claim 5, the data file of claim 1 is as described. Uemura teaches wherein the medical information is secured when an indicator associated with at least one of the data fields is enabled (Uemura: figures 2-3).
As per claim 6, the data file of claim 1 is as described. Uemura teaches wherein the one or more layers includes a blurred region that hides at least a portion of the one or more patient images (Uemura: para. 52; figure 4B; Painted with a light color and it’s difficult to read contents but possible to visually recognize the content in the area (i.e. blurry).).
As per claim 7, the data file of claim 1 is as described. Uemura teaches wherein the one or more layers includes a blacked-out region that hides at least a portion of the one or more patient images (Uemura: para. 51; figure 4A; Painted with dark color (i.e. black).).
As per claim 8, the data file of claim 1 is as described. Uemura teaches wherein the pass code is a password or an identifier associated with a computing device (Uemura: para. 91).
As per claim 9, the data file of claim 1 is as described. Uemura teaches wherein the one or more patient images includes one or more of: a two-dimensional image, a three-dimensional image, an x-ray image, digital image and an analog image (Uemura: figure 2; document containing photo).
As per claim 10, the data file of claim 1 is as described. Uemura teaches wherein one or more layers include modifications and/or comments associated with the one or more patient images (Uemura: para. 49).
As per claim 11, the data file of claim 1 is as described. Uemura teaches wherein the one or more patient images comprise one or more of: one or more facial anterior repose images, one or more facial anterior smiling images, one or more profile repose images, one or more profile smiling images, one or more right buccal images, one or more left buccal images, one or more anterior intraoral images, one or more upper occlusal images, one or more lower occlusal images, one or more close-up smile images, one or more individual teeth images, and one or more patient medical history images (Uemura: figure 2; medical history could contain images).
As per claim 12, the data file of claim 1 is as described. Uemura teaches wherein the one or more layers does not cover the patient’s teeth in the one or more patient images such that the patient’s teeth are viewable (Uemura: para. 52; figure 4B; Painted with a light color and it’s difficult to read contents but possible to visually recognize the content in the area (i.e. blurry).).
As per claim 13, Uemura teaches a clinical data file for securing medical information, comprising:
-medical information arranged in corresponding data fields, the medical information comprising one or more of: treatment professional information, patient personal information, and one or more patient images (Uemura: figure 3; address, photo, and medical history); and
-an indicator associated with at least one of the data fields, wherein when enabled, the indicator is configured to secure a securable portion of the medical information in a corresponding data field (Uemura: figures 2-3; para. 38; para. 91-92; para. 95; Providing the original document that was scanned with data fields and the user selecting fields and setting confidential level, encryption degree.).
Uemura does not explicitly teach the following, however, Onishi teaches:
-wherein when the clinical data file is viewed by a third party, a viewable portion of the medical information is viewable and the securable portion of the medical information is covered and hidden by one or more layers (Onishi: para. 16-18; para. 22; para. 28; Concealment unit encrypts part of the image data in an image layer. Output is superimposed layers.), the securable portion, including at least a part of the one or more patient images, wherein the one or more layers is removable by entering a pass code (Onishi: para. 39-40; Provide password input to show viewing rights.).
The motivation to combine the teachings is same as claim 1.
Claim 14 recite substantially similar limitations as those already addressed in claim 4, and, as such, are rejected for similar reasons as given above.
Claims 15-16 recite substantially similar limitations as those already addressed in claims 9-10, and, as such, are rejected for similar reasons as given above.
Claims 17-18 recite substantially similar limitations as those already addressed in claims 6-7, and, as such, are rejected for similar reasons as given above.
Claim 19 recite substantially similar limitations as those already addressed in claim 2, and, as such, are rejected for similar reasons as given above.
Claims 3 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Uemura (U.S. Publication No. 2008/0133274) in view of Onishi et al. (JP 2004/289456A) and further in view of Warner (U.S. Publication No. 2008/0133274).
As per claim 3, the data file of claim 2 is as described. Uemura and Onishi do not explicitly teach the following, however, Warner teaches wherein the single format is a portable document format (PDF) (Warner: para. 121).
One of ordinary skill in the art would have recognized that applying the known technique of Warner would have yielded predictable results and resulted in an improved system. It would have been recognized that applying the technique of Warner to the teachings of Uemura in view of Onishi would have yielded predictable results because the level of ordinary skill in the art demonstrated by the references applied shows the ability to incorporate such features into similar systems. Further, applying medical documents to be in PDF format to Uemura teaching document scanning in a format would have been recognized by those of ordinary skill in the art as resulting in an improved system that would provide a system that managed medical records data electronically and provide faster access (Warner: para. 2, 7).
Claim 20 recite substantially similar limitations as those already addressed in claim 3, and, as such, are rejected for similar reasons as given above.
Response to Arguments
Applicant’s arguments, see pg. 2-3, filed 10/10/2025, with respect to 35 U.S.C. 101 have been fully considered and are persuasive. The 35 U.S.C. 101 rejection of claims 1-20 has been withdrawn.
Applicant’s arguments with respect to claim(s) 1-20 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Black et al. – U.S. Publication No. 2006/0075228 – Teaches a process for encrypting sensitive information in a document.
Hochberg et al. – WO 2005/041100 – Teaches a system for providing access to clinical data specifically.
THIS ACTION IS MADE FINAL. 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.
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/SHEETAL R PAULSON/Primary Examiner, Art Unit 3681