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 .
DETAILED ACTION
Status of the Application
Claims 1-20 are currently pending in this case and have been examined and addressed below. This communication is a Non-Final Rejection in response to the Claims filed on 09/04/2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/21/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. However, in view of the excessive volume of references provided, Examiner was only able to give a cursory review of the documents.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 15, and 20 recite one or more data models of anomalous behavior that are rarely observed but highly indicative of diversion. However, it is unclear what the metes and bounds of the one or more data models are. It is unclear whether this is merely a label for the data model or this is describing the functionality of the data model such that this is a data model that identifies anomalous behavior that are rarely observed but highly indicative of diversion. Even if that is the case, it is unclear how the model would determine anomalous behavior as rarely observed but highly indicative of diversion. The term rarely observed is a relative term that is not defined and one of ordinary skill in the art would not know what meets the level of rarely observed. Similarly, highly indicative of diversion is a relative term that is not defined and one of ordinary skill in the art would not known what meets the level of highly indicative of diversion. For purposes of examination, Examiner will interpret the data model to be a model which identifies entities whose behavior is anomalous by diverging from the expected behavior which indicates prescription drug fraud/abuse.
As per Claims 2-14 and 16-19, the claims depend on Claims 1 and 15 and do not remedy the indefiniteness issues of Claims 1 and 15. As dependent claims inherit the deficiencies of the claims they depend on, they are also rejected.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-13, 15-18, 20-22 and 33 of U.S. Patent No. 12,437,862 in view of Hermiz et al (US 2014/0257832 A1).
Although the conflicting claims are not identical, they are not patentably distinct from each other. Claim 1 of the instant application and Claim 1 of the ‘862 Patent are drawn to a system of determining an infrequent activity pattern corresponds to anomalous behavior, triggering an investigative workflow, and causing a wasting station to provide an isolated unused receptacle for unused medications for a physician determined to have anomalous behavior. Claim 15 of the instant application and Claim 17 of the ‘862 patent are both drawn to a computer-implemented method of determining an infrequent activity pattern corresponds to anomalous behavior, triggering an investigative workflow, and causing a wasting station to provide an isolated unused receptacle for unused medications for a physician determined to have anomalous behavior. Claim 20 of the instant application and Claim 33 of the ‘862 patent are both drawn to a non-transitory computer readable medium storing instructions to perform operations of determining an infrequent activity pattern corresponds to anomalous behavior, triggering an investigative workflow, and causing a wasting station to provide an isolated unused receptacle for unused medications for a physician determined to have anomalous behavior. The claim limitations of these two inventions are substantially identical with the exception of specifically the data models used to determine whether the infrequent activity pattern corresponds to an anomalous behavior are data models of anomalous behavior that are rarely observed but highly indicative of diversion.
Claim 1 of the ’862 patent embodies all of the limitations of Claim 1 of the instant application with the exception of: data models of anomalous behavior that are rarely observed but highly indicative of diversion. At the time the application was filed, data models of anomalous behavior that are rarely observed but highly indicative of diversion, were old and well-known to persons having ordinary skill in the art. For example, U.S. Patent Application Publication No. 2014/0257832 by inventor Hermiz at Abstract which discloses models used to identify entities whose behavior diverges from the expected behavior, i.e. anomalous behavior and is statistically significant for abnormal behavior, Pars [0029-0030] discloses, identifying entities with abnormal claims behavior which includes prescription drug abuse or fraud (i.e. drug diversion) by use of a baseline model.
Claims 17 and 33 of the ‘862 patent embodies all the limitations of Claims 15 and 20 of the instant application, respectively with the exception of the same subject matter as described above in Claim 1 and are therefore not patentably distinct from the ‘864 Patent in view of Hermiz.
Claims 2, 4-13, 15-16, 18, and 20-22 of the ‘862 patent embody all the same additional limitations as claims 2-14 and 16-19 of the instant application.
For these reasons, the claims of the instant application are not identical to claims 1-2, 4-13, 15-18, 20-22 and 33 of U.S. Patent No. 12,437,862 but they are not patentably distinct.
Subject Matter Free of the Prior Art
The following is an examiner’s statement of subject matter free of the prior art: The combination of limitations in Claims 1, 15, and 20 stating: using signal-to-noise ratio being below a threshold value to identify an infrequent activity pattern for a clinician and causing a wasting station to provide a separate receptacle which isolates unused medications disposed by a first clinician from the medications wasted from other physicians is free of the prior art. The most remarkable prior arts of record are as follows:
Tribble et al. (US 2017/0109497 A1) teaches identifying an activity pattern for a physician as infrequent and corresponding to anomalous behavior which triggers an investigation.
Yanowitz et al. (US 2019/0088354 A1) teaches a second physician witnessing wasting of medication for an additional physician and routine selection of a particular physician to witness medication wasting.
D'Amato (US 2018/0247703 A1) teaches a system for analyzing data from an automated medication dispensing system to identify possible drug diversion events.
Hermiz et al. (US 2014/0257832 A1) teaches data models are used to identify entities whose behavior diverges from the expected behavior, i.e. anomalous behavior and is statistically significant for abnormal behavior, and identifying entities with abnormal claims behavior which includes prescription drug abuse or fraud (i.e. drug diversion) by use of a baseline model.
None of Tribble, Yanowitz, D’Amato, or Hermiz teach on using signal-to-noise ratio being below a threshold value to identify an infrequent activity pattern for a clinician and causing a wasting station to provide a separate receptacle which isolates unused medications disposed by a first clinician from the medications wasted from other physicians. Therefore, claims 1-20 are free of the prior art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure for the reasons discussed above.
Tribble et al. (US 2017/0109497 A1)
Yanowitz et al. (US 2019/0088354 A1)
D'Amato (US 2018/0247703 A1)
Hermiz et al. (US 2014/0257832 A1)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evangeline Barr whose telephone number is (571)272-0369. The examiner can normally be reached Monday to Friday 8:00 am to 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached at 571-270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EVANGELINE BARR/Primary Examiner, Art Unit 3682
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