DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,042,226 in view of Stark et al. (US 2004/0246441).
Claim 1 of U.S. Patent No. 12,046,226 discloses a method comprising: collecting a pupil data profile comprising pupil diameter measurements as a function of time; determining whether the following conditions are met; (i) no more than two data points exist representing the same pupil diameter at separate points in time during a period of no more than about four seconds, (ii) a first phase of the pupillary reflex response exists, wherein said first phase is characterized by a period of non-constriction immediately subsequent to stimulating the pupil, said first phase having a duration of greater than about 100 msec and less than about 1000 msec, (iii) if two data points exist representing the same pupil diameter at two separate points in time, then the duration of time between said two separate points in time is greater than about 100 msec, and (iv) during the first phase of the pupillary reflex, the diameter of the pupil does not increase before it decreases; and providing an output indicating that the pupil reflex does not resemble a canonical reflex if one or more of said conditions is not met.
U.S. Patent No. 12,046,226 does not disclose using the pupilometer to provide an output indicating that said subject has an elevated level of intracranial pressure if one or more of said conditions is not met.
In a related endeavor, Stark discloses a method using a pupilometer to collect pupil data from said subject (Fig. 1-2); and using the pupilometer to provide an output indicating that said subject has an elevated level of intracranial pressure if one or more of said conditions is not met (Para. 0025-0026).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the method, as taught by Stark, with the method, as claimed by U.S. Patent No. 12,046,226 for the purpose of providing a method with accurate and improved diagnosis.
Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 8,393,734 in view of Stark et al. (US 2004/0246441).
Claims 1-9 of U.S. Patent No. 8,393,734 discloses a method comprising: collecting a pupil data profile comprising pupil diameter measurements as a function of time; determining whether the following conditions are met; (i) no more than two data points exist representing the same pupil diameter at separate points in time during a period of no more than about four seconds, (ii) a first phase of the pupillary reflex response exists, wherein said first phase is characterized by a period of non-constriction immediately subsequent to stimulating the pupil, said first phase having a duration of greater than about 100 msec and less than about 1000 msec, (iii) if two data points exist representing the same pupil diameter at two separate points in time, then the duration of time between said two separate points in time is greater than about 100 msec, and (iv) during the first phase of the pupillary reflex, the diameter of the pupil does not increase before it decreases; and providing an output indicating that the pupil reflex does not resemble a canonical reflex if one or more of said conditions is not met.
U.S. Patent No. 8,393,734 does not disclose using the pupilometer to provide an output indicating that said subject has an elevated level of intracranial pressure if one or more of said conditions is not met.
In a related endeavor, Stark discloses a method using a pupilometer to collect pupil data from said subject (Fig. 1-2); and using the pupilometer to provide an output indicating that said subject has an elevated level of intracranial pressure if one or more of said conditions is not met (Para. 0025-0026).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the method, as taught by Stark, with the method, as claimed by U.S. Patent No. 8,393,734 for the purpose of providing a method with accurate and improved diagnosis.
Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over 1-5 of U.S. Patent No. 8,911,085 in view of Stark et al. (US 2004/0246441).
Claims 1-5 of U.S. Patent No. 8,911,085 discloses a method comprising: collecting a pupil data profile comprising pupil diameter measurements as a function of time; determining whether the following conditions are met; (i) no more than two data points exist representing the same pupil diameter at separate points in time during a period of no more than about four seconds, (ii) a first phase of the pupillary reflex response exists, wherein said first phase is characterized by a period of non-constriction immediately subsequent to stimulating the pupil, said first phase having a duration of greater than about 100 msec and less than about 1000 msec, (iii) if two data points exist representing the same pupil diameter at two separate points in time, then the duration of time between said two separate points in time is greater than about 100 msec, and (iv) during the first phase of the pupillary reflex, the diameter of the pupil does not increase before it decreases; and providing an output indicating that the pupil reflex does not resemble a canonical reflex if one or more of said conditions is not met.
U.S. Patent No. 8,911,085 does not disclose using the pupilometer to provide an output indicating that said subject has an elevated level of intracranial pressure if one or more of said conditions is not met.
In a related endeavor, Stark discloses a method using a pupilometer to collect pupil data from said subject (Fig. 1-2); and using the pupilometer to provide an output indicating that said subject has an elevated level of intracranial pressure if one or more of said conditions is not met (Para. 0025-0026).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the method, as taught by Stark, with the method, as claimed by U.S. Patent No. 8,911,085 for the purpose of providing a method with accurate and improved diagnosis.
Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over 1-10 of U.S. Patent No. 9,220,408 in view of Stark et al. (US 2004/0246441).
Claims 1-10 of U.S. Patent No. 9,220,408 discloses a method comprising: collecting a pupil data profile comprising pupil diameter measurements as a function of time; determining whether the following conditions are met; (i) no more than two data points exist representing the same pupil diameter at separate points in time during a period of no more than about four seconds, (ii) a first phase of the pupillary reflex response exists, wherein said first phase is characterized by a period of non-constriction immediately subsequent to stimulating the pupil, said first phase having a duration of greater than about 100 msec and less than about 1000 msec, (iii) if two data points exist representing the same pupil diameter at two separate points in time, then the duration of time between said two separate points in time is greater than about 100 msec, and (iv) during the first phase of the pupillary reflex, the diameter of the pupil does not increase before it decreases; and providing an output indicating that the pupil reflex does not resemble a canonical reflex if one or more of said conditions is not met.
U.S. Patent No. 9,220,408 does not disclose using the pupilometer to provide an output indicating that said subject has an elevated level of intracranial pressure if one or more of said conditions is not met.
In a related endeavor, Stark discloses a method using a pupilometer to collect pupil data from said subject (Fig. 1-2); and using the pupilometer to provide an output indicating that said subject has an elevated level of intracranial pressure if one or more of said conditions is not met (Para. 0025-0026).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the method, as taught by Stark, with the method, as claimed by U.S. Patent No. 9,220,408 for the purpose of providing a method with accurate and improved diagnosis.
Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over 1-10 of U.S. Patent No. 10,149,614 in view of Stark et al. (US 2004/0246441).
Claims 1-10 of U.S. Patent No. 10,149,614 discloses a method comprising: collecting a pupil data profile comprising pupil diameter measurements as a function of time; determining whether the following conditions are met; (i) no more than two data points exist representing the same pupil diameter at separate points in time during a period of no more than about four seconds, (ii) a first phase of the pupillary reflex response exists, wherein said first phase is characterized by a period of non-constriction immediately subsequent to stimulating the pupil, said first phase having a duration of greater than about 100 msec and less than about 1000 msec, (iii) if two data points exist representing the same pupil diameter at two separate points in time, then the duration of time between said two separate points in time is greater than about 100 msec, and (iv) during the first phase of the pupillary reflex, the diameter of the pupil does not increase before it decreases; and providing an output indicating that the pupil reflex does not resemble a canonical reflex if one or more of said conditions is not met.
U.S. Patent No. 10,149,614 does not disclose using the pupilometer to provide an output indicating that said subject has an elevated level of intracranial pressure if one or more of said conditions is not met.
In a related endeavor, Stark discloses a method using a pupilometer to collect pupil data from said subject (Fig. 1-2); and using the pupilometer to provide an output indicating that said subject has an elevated level of intracranial pressure if one or more of said conditions is not met (Para. 0025-0026).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the method, as taught by Stark, with the method, as claimed by U.S. Patent No. 10,149,614 for the purpose of providing a method with accurate and improved diagnosis.
Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over 1-4 of U.S. Patent No. 10,786,152 in view of Stark et al. (US 2004/0246441).
Claims 1-4 of U.S. Patent No. 10,786,152 discloses a method comprising: collecting a pupil data profile comprising pupil diameter measurements as a function of time; determining whether the following conditions are met; (i) no more than two data points exist representing the same pupil diameter at separate points in time during a period of no more than about four seconds, (ii) a first phase of the pupillary reflex response exists, wherein said first phase is characterized by a period of non-constriction immediately subsequent to stimulating the pupil, said first phase having a duration of greater than about 100 msec and less than about 1000 msec, (iii) if two data points exist representing the same pupil diameter at two separate points in time, then the duration of time between said two separate points in time is greater than about 100 msec, and (iv) during the first phase of the pupillary reflex, the diameter of the pupil does not increase before it decreases; and providing an output indicating that the pupil reflex does not resemble a canonical reflex if one or more of said conditions is not met.
U.S. Patent No. 10,786,152 does not disclose using the pupilometer to provide an output indicating that said subject has an elevated level of intracranial pressure if one or more of said conditions is not met.
In a related endeavor, Stark discloses a method using a pupilometer to collect pupil data from said subject (Fig. 1-2); and using the pupilometer to provide an output indicating that said subject has an elevated level of intracranial pressure if one or more of said conditions is not met (Para. 0025-0026).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the method, as taught by Stark, with the method, as claimed by U.S. Patent No. 10,786,152 for the purpose of providing a method with accurate and improved diagnosis.
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 06/03/2026
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