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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/12/2025 and 06/17/2026 have been considered by the examiner.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,171,496. Although the claims at issue are not identical, they are not patentably distinct from each other because the removal of the limitations “detecting, based on the infrared stream at a second time later than the first time, that the eye is properly aligned using the machine learning model; and responsive to detecting that the eye is properly aligned, automatically instructing the capture of an image of the retina of the properly aligned eye from the imaging device and receiving the image” renders claims 1-20 of the instant application as broadened and obvious variants of claims 1-20 of U.S. Patent No. 12,171,496.
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 1-3, 9-12, 14 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Swedish et al. (US 2016/0302665; already of record) in view of Fukui (JP 3790680; already of record).
Regarding claim 1, Swedish discloses, a method for detecting eye alignment during retinal imaging (Figs. 1-12B), the method comprising:
receiving an infrared stream (Para. 0181, 0203 and see 701, 711) from an imaging device (Para. 0089 and see 101, 721, 722), the infrared stream showing infrared absorption within a retina of an eye of a patient (Para. 0156, 0164-0166 and see 103);
inputting a frame of the infrared stream into a model (Para. 0013-0015, 0094-0096 and 0222);
receiving as output from the model information indicating the eye is improperly aligned at a first time (Para. 0013-0015, 0021-0022 and 0222); and
responsive to receiving the output from the model, outputting sensory feedback indicative of the improper alignment (Para. 0013-0015, 0021-0022 and 0222).
Swedish does not disclose the model is machine learning model, and responsive to receiving the output from the machine learning model, outputting sensory feedback indicative of the improper alignment.
Fukui teaches, from the same field of endeavor that in a method for detecting eye alignment that it would have been desirable to make the model is machine learning model (Para. 0008, 0081, 0106 and see 6, 9 of Fig. 4), and responsive to receiving the output from the machine learning model, outputting sensory feedback indicative of the improper alignment (Para. 0008, 0081, 0106 and see 6, 9 of Fig. 4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the model is machine learning model, and responsive to receiving the output from the machine learning model, outputting sensory feedback indicative of the improper alignment as taught by the method for detecting eye alignment of Fukui in the method for detecting eye alignment of Swedish since Fukui teaches it is known to include these features in a method for detecting eye alignment for the purpose of providing an accurate and effective method for detecting eye alignment.
Regarding claims 2, 11 and 20, Swedish in view of Fukui discloses and teaches as set forth above, and Swedish further discloses, the information indicates that the eye is improperly aligned at the first time due to at least one of: a pupil of the eye is not shown in the infrared stream (Para. 0118, 0144 and 0222); and the imaging device is not focused (Para. 0118, 0144 and 0222).
Regarding claims 3 and 12, Swedish in view of Fukui discloses and teaches as set forth above, and Swedish further discloses, the imaging device is operated autonomously, and wherein the sensory feedback comprises a visual or aural output to the patient with instructions on how to correct the improper alignment (Para. 0013-0015, 0021-0022, 0171 and 0222).
Regarding claims 5 and 14, Swedish in view of Fukui discloses and teaches as set forth above, and Swedish further discloses, responsive to detecting that the eye is properly aligned, commanding the imaging device to capture the image (Para. 0013-0015, 0094-0096, 0222 and see 101, 721-722).
Regarding claims 9 and 18, Swedish in view of Fukui discloses and teaches as set forth above, and Swedish further discloses, autonomously diagnosing a retinal condition of the retina based on features of the image of the retina (Para. 0143).
Regarding claim 10, Swedish discloses, a computer program product for detecting eye alignment during retinal imaging (Figs. 1-12B), the computer program product comprising a non-transitory computer-readable storage medium containing computer program code (Figs. 1-12B) for, the method comprising:
receiving an infrared stream (Para. 0181, 0203 and see 701, 711) from an imaging device (Para. 0089 and see 101, 721, 722), the infrared stream showing infrared absorption within a retina of an eye of a patient (Para. 0156, 0164-0166 and see 103);
inputting a frame of the infrared stream into a model (Para. 0013-0015, 0094-0096 and 0222);
receiving as output from the model information indicating the eye is improperly aligned at a first time (Para. 0013-0015, 0021-0022 and 0222); and
responsive to receiving the output from the model, outputting sensory feedback indicative of the improper alignment (Para. 0013-0015, 0021-0022 and 0222).
Swedish does not disclose the model is machine learning model, and responsive to receiving the output from the machine learning model, outputting sensory feedback indicative of the improper alignment.
Fukui teaches, from the same field of endeavor that in a method for detecting eye alignment that it would have been desirable to make the model is machine learning model (Para. 0008, 0081, 0106 and see 6, 9 of Fig. 4), and responsive to receiving the output from the machine learning model, outputting sensory feedback indicative of the improper alignment (Para. 0008, 0081, 0106 and see 6, 9 of Fig. 4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the model is machine learning model, and responsive to receiving the output from the machine learning model, outputting sensory feedback indicative of the improper alignment as taught by the method for detecting eye alignment of Fukui in the method for detecting eye alignment of Swedish since Fukui teaches it is known to include these features in a method for detecting eye alignment for the purpose of providing an accurate and effective method for detecting eye alignment.
Regarding claim 19, Swedish discloses, a system for detecting eye alignment during retinal imaging (Figs. 1-12B), the system comprising:
Memory (850, 851) with instructions encoded thereon; and
one or more processors (811, 812) that, when executed, are caused to perform operations comprising:
receiving an infrared stream (Para. 0181, 0203 and see 701, 711) from an imaging device (Para. 0089 and see 101, 721, 722), the infrared stream showing infrared absorption within a retina of an eye of a patient (Para. 0156, 0164-0166 and see 103);
inputting a frame of the infrared stream into a model (Para. 0013-0015, 0094-0096 and 0222);
receiving as output from the model information indicating the eye is improperly aligned at a first time (Para. 0013-0015, 0021-0022 and 0222); and
responsive to receiving the output from the model, outputting sensory feedback indicative of the improper alignment (Para. 0013-0015, 0021-0022 and 0222).
Swedish does not disclose the model is machine learning model, and responsive to receiving the output from the machine learning model, outputting sensory feedback indicative of the improper alignment.
Fukui teaches, from the same field of endeavor that in a system for detecting eye alignment that it would have been desirable to make the model is machine learning model (Para. 0008, 0081, 0106 and see 6, 9 of Fig. 4), and responsive to receiving the output from the machine learning model, outputting sensory feedback indicative of the improper alignment (Para. 0008, 0081, 0106 and see 6, 9 of Fig. 4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the model is machine learning model, and responsive to receiving the output from the machine learning model, outputting sensory feedback indicative of the improper alignment as taught by the system for detecting eye alignment of Fukui in the system for detecting eye alignment of Swedish since Fukui teaches it is known to include these features in a system for detecting eye alignment for the purpose of providing an accurate and effective system for detecting eye alignment.
Claims 4 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Swedish et al. (US 2016/0302665; already of record) in view of Fukui (JP 3790680; already of record) as applied to claims 1 and 10 above, and further in view of Koehler et al. (US 2019/0028654; already of record).
Swedish in view of Fukui remains as applied to claims 1 and 10 above.
Swedish in view of Fukui does not disclose the imaging device is operated by an operator other than the patient, and wherein the sensory feedback is provided to the operator.
Koehler teaches, from the same field of endeavor that in a method for detecting eye alignment that it would have been desirable to make the imaging device is operated by an operator other than the patient, and wherein the sensory feedback is provided to the operator (Para. 0004-0005 and see 210 of Fig. 2 and associated text).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the imaging device is operated by an operator other than the patient, and wherein the sensory feedback is provided to the operator as taught by the method for detecting eye alignment of Koehler in the combination of Swedish in view of Fukui since Koehler teaches it is known to include this feature in a method for detecting eye alignment for the purpose of providing an accurate and effective method for detecting eye alignment.
Claims 5-8 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Swedish et al. (US 2016/0302665; already of record) in view of Fukui (JP 3790680; already of record) as applied to claims 5 and 14 above, and further in view of Keshishian (US 2019/008258; already of record).
Swedish in view of Fukui remains as applied to claims 5 and 14 above.
Swedish in view of Fukui does not disclose responsive to detecting that the eye is properly aligned, commanding the imaging device to capture the image.
Keshishian teaches, from the same field of endeavor that in a method for detecting eye alignment that it would have been desirable to include responsive to detecting that the eye is properly aligned, commanding the imaging device to capture the image (Para. 0056 and 0100).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make detecting that the eye is properly aligned comprises detecting a twitch of the eye as taught by the method for detecting eye alignment of Keshishian in the combination of Swedish in view of Fukui since Keshishian teaches it is known to include this feature in a method for detecting eye alignment for the purpose of providing a method for detecting eye alignment with accurate alignment and analysis.
Regarding claims 7 and 16, Swedish, Fukui and Keshishian discloses and teaches as set forth above, and Keshishian further teaches, from the same field of endeavor that in a method for detecting eye alignment that it would have been desirable to make detecting that the eye is properly aligned further comprises: responsive to detecting the twitch, capturing a candidate image; determining whether the candidate image satisfies a quality parameter; and responsive to determining that the candidate image satisfies the quality parameter, determining that the eye is properly aligned (Para. 0056 and 0100).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the method for detecting eye alignment of Keshishian in the combination of Swedish in view of Fukui since Keshishian teaches it is known to include this feature in a method for detecting eye alignment for the purpose of providing a method for detecting eye alignment with accurate alignment and analysis.
Regarding claims 8 and 17, Swedish, Fukui and Keshishian discloses and teaches as set forth above, and Keshishian further teaches, the quality parameter comprises at least one of image quality in the candidate image and detection of an artifact in the candidate image (Para. 0056 and 0100).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the above mentioned limitations as taught by the method for detecting eye alignment of Keshishian in the combination of Swedish in view of Fukui since Keshishian teaches it is known to include this feature in a method for detecting eye alignment for the purpose of providing a method for detecting eye alignment with accurate alignment and analysis.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWAYNE A PINKNEY whose telephone number is (571)270-1305. The examiner can normally be reached M-F 9-5.
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/DAWAYNE PINKNEY/Primary Examiner, Art Unit 2872 07/28/2026
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