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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 ----09/15/2025 has been entered.
Status of Claims
Claims 1-3, 5, 12-15, 17-20, 22, and 29-32 are currently pending and have been examined.
Claims 1 and 18 have been amended. Examiner notes that claim 22 states, “(currently amended),” however, there are no amendments present.
Claims 4, 6-11, 16, 21, 23-28 and 33-40 have been canceled, with 4 and 21 being newly canceled in the response filed 09/15/2025.
Claims 1-3, 5, 12-15, 17-20, 22, and 29-32 have been rejected.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 5, 12-15, 17-20, 22, and 29-32 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.
Claim 1 discloses, “distributing pharmaceuticals to be dispensed according to said pharmaceutical dispensing schedule to said at least one first pharmaceutical dispensing machine and distributing only a subset of non-scheduled pharmaceuticals to said at least one second pharmaceutical dispensing machine.” The claim does not disclose distributing the remaining non-scheduled pharmaceuticals to either pharmaceutical dispensing machine. It is unclear if these remaining non-scheduled pharmaceuticals would not be distributed at all or if they would also be distributed to the first pharmaceutical dispensing machine with the larger pharmaceutical storage capacity.
Claim 18 does not disclose distributing or “including” any pharmaceuticals in the first pharmaceutical dispensing machine and other than “pharmaceuticals that are expected to be dispensed together are distributed to the same pharmaceutical dispensing machine albeit of their scoring.” The claim does not disclose distributing pharmaceuticals to be dispensed according to said pharmaceutical dispensing schedule therefore it is unclear if or when the pharmaceuticals in the pharmaceutical dispensing schedule would be distributed. Nor does the claim disclose distributing the remaining non-scheduled pharmaceuticals to either pharmaceutical dispensing machine. It is unclear if these remaining non-scheduled pharmaceuticals would not be distributed at all or if they would also be distributed to the first pharmaceutical dispensing machine with the larger pharmaceutical storage capacity.
Claim 1 further discloses, “finding a subset of said non-scheduled pharmaceuticals which reduces said expected disruption based on said scoring” and claim 18 discloses, “selecting a subset that reduces said expected disruption.” It is unclear if “reduces said expected disruption based on said scoring” and “reduces said expected disruption” is because the subset of non-scheduled pharmaceuticals disrupts the schedule of the first pharmaceutical dispensing machine and removal of this subset would result in a reduction in the expected disruption or if the subset of said non-scheduled pharmaceuticals being present in the first pharmaceutical dispensing machine reduces the expected disruption. The Examiner is interpreting the limitation to disclose the first interpretation where removal of the subset would result in a reduction in the expected disruption.
Dependent claims 2-3, 5, 12-15, 17, 19-20, 22, and 29-32 are rejected as dependent on a rejected base claim.
Thus, claims 1-3, 5, 12-15, 17-20, 22, and 29-32 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.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3, 5, 12-15, 17-20, 22, and 29-32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claimed invention is directed to an abstract idea without significantly more. Claims 1-3, 5, 12-15, 17-20, 22, and 29-32 are directed to a system, method, or product which are one of the statutory categories of invention. (Step 1: YES).
Independent Claim 1 discloses a method of distributing pharmaceuticals in a pharmaceutical dispensing system, said pharmaceutical dispensing system comprising at least one first pharmaceutical dispensing machine configured to store, package and dispense pharmaceuticals in batches according to a pharmaceutical dispensing schedule, at least one second pharmaceutical dispensing machine configured to store, package and dispense non-scheduled pharmaceuticals in response to at least one non-scheduled demand, said at least one second pharmaceutical dispensing machine comprising a limited pharmaceutical storage capacity which is less than a pharmaceutical storage capacity of said at least one first pharmaceutical dispensing machine, the method comprising: a. distributing pharmaceuticals to be dispensed according to said pharmaceutical dispensing schedule to said at least one first pharmaceutical dispensing machine and distributing only a subset of non-scheduled pharmaceuticals to said at least one second pharmaceutical dispensing machine; said distributing only a subset of non-scheduled pharmaceuticals to said at least one second pharmaceutical dispensing machine comprising determining said subset by: i. scoring each non-scheduled pharmaceutical by a degree of expected disruption caused to said pharmaceutical dispensing schedule by dispensing thereof by said at least one first pharmaceutical dispensing machine; ii. finding a subset of said non-scheduled pharmaceuticals which reduces said expected disruption based on said scoring and also fits in said limited pharmaceutical storage capacity of said at least one second pharmaceutical dispensing machine; and wherein pharmaceuticals that expected to be dispensed together are distributed to the same pharmaceutical dispensing machine albeit of their scoring b. physically distributing and storing said pharmaceuticals according to a result of said determining.
Independent Claim 18 discloses a pharmaceutical dispensing system, comprising: a. at least one first pharmaceutical dispensing machine for storing, packing and dispensing one or more pharmaceuticals in batches according to a pharmaceutical dispensing schedule; and b. at least one second pharmaceutical dispensing machine for storing, packing and dispensing one or more non-scheduled pharmaceuticals in response to at least one non-scheduled demand, said at least one second pharmaceutical dispensing machine being located in proximity to users and having a storage capacity that is less than a storage capacity of said at least one first pharmaceutical dispensing machine; wherein the system is configured such that; i. said one or more non-scheduled pharmaceuticals included in said at least one second pharmaceutical dispensing machine are selected by scoring each non-scheduled pharmaceutical by a degree of expected disruption that would be caused to said pharmaceutical dispensing schedule if dispensed by said at least one first pharmaceutical dispensing machine and selecting a subset that reduces said expected disruption while fitting within said storage capacity of said at least one second pharmaceutical dispensing machine; and ii. Pharmaceuticals that are expected to be dispensed together are distributed to the same pharmaceutical dispensing machine albeit of their scoring.
The examiner is interpreting the above bolded limitations as additional elements as further discussed below. The remaining un-bolded limitations, given the broadest reasonable interpretation, cover the abstract idea of a mental process because they recite a process that could be practically performed in the human mind (i.e. observations, evaluations, judgements, and/or opinions – in this case, the steps of a and b of claim 1 and steps i and ii of claim 18 wherein a human could, to paraphrase, distribute pharmaceuticals based on a score, a limited storage capacity, and if the pharmaceuticals need to be dispensed together).
Further, the remaining un-bolded limitations are merely directed to rules a user would use to determine where pharmaceuticals should be stocked. The series of steps recited above describe managing personal behavior or relationships or interactions between people and thus are grouped as certain methods of organizing human activity which is an abstract idea. The abstract ideas are considered together as a single abstract idea for further analysis. (Step 2A- Prong 1: YES. The claims are abstract).
This judicial exception is not integrated into a practical application. Limitations that are not indicative of integration into a practical application include: (1) Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (MPEP 2106.05.f), (2) Adding insignificant extra- solution activity to the judicial exception (MPEP 2106.05.g), (3) Generally linking the use of the judicial exception to a particular technological environment or field of use (MPEP 2106.05.h).
Independent Claim 1 discloses the following additional elements:
A pharmaceutical dispensing system comprising at least one first and second pharmaceutical dispensing machine
Said at least one second pharmaceutical dispensing machine comprising a limited pharmaceutical storage capacity which is less than a pharmaceutical storage capacity of said at least one first pharmaceutical dispensing machine
Independent Claim 18 discloses the following additional elements:
A pharmaceutical dispensing system comprising at least one first and second pharmaceutical dispensing machine
Said at least one second pharmaceutical dispensing machine.. having a storage capacity that is less than a storage capacity of said at least one first pharmaceutical dispensing
In particular, the pharmaceutical dispensing system comprising at least one first and second pharmaceutical dispensing machine of claim 1 and 18 and the at least one second pharmaceutical dispensing machine comprising a limited pharmaceutical storage capacity which is less than a pharmaceutical storage capacity of said at least one first pharmaceutical dispensing machine of claims 1 and 18 are recited at a high-level of generality such that it amounts to no more than mere instructions to implement an abstract idea (including storing, packaging, and dispensing pharmaceuticals) by adding the words ‘apply it’ (or an equivalent) with the judicial exception.
The Examiner notes that there is no disclosure of a machine (for example: a computer, a processor) that is determining the score of the pharmaceuticals. Further, the dispensing machines never dispense any pharmaceuticals in the claim, it is merely claimed that they have the ability to. The instant application does not claim a machine for distributing the pharmaceuticals to the two dispensing machines. As such, the broadest reasonable interpretation of the claim language, could be interpreted as a human distributing the pharmaceuticals based on a score the human calculated.
Applicant’s specification states on Page 11, lines 8-17 - these computer program instructions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks. These computer program instructions may also be stored in a computer readable medium that can direct a computer, other programmable data processing apparatus, or other devices to function in a particular manner, such that the instructions stored in the computer readable medium produce an article of manufacture including instructions which implement the function/act specified in the flowchart and/or block diagram block or blocks.
Even if the claim was amended to include the computer, the specification discloses the computer as a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine. Thus, the computer is performing as expected and is not improved in any way.
Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Thus, claim(s) 1 and 18 are directed to an abstract idea(s) without a practical application. (Step 2A-Prong 2: NO: the additional claimed elements are not integrated into a practical application).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of the pharmaceutical dispensing system comprising at least one first and second pharmaceutical dispensing machine of claim 1 and 18 and the at least one second pharmaceutical dispensing machine comprising a limited pharmaceutical storage capacity which is less than a pharmaceutical storage capacity of said at least one first pharmaceutical dispensing machine of claims 1 and 18 amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more’). MPEP2106.05(I)(A) indicates that merely saying "apply it” or equivalent to the abstract idea cannot provide an inventive concept ("significantly more"). Accordingly, even in combination, this additional element does not provide significantly more. As such the independent claims 1 and 18 are not patent eligible. (Step 2B: NO. The claims do not provide significantly more).
Dependent claim(s) 2-3, 5, 12-15, 17 and 19-20, 22, and 29-32 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. Dependent claims 2-3, 5, 12-15, 17 and 19-20, 22, and 29-32 do not further disclose any additional elements.
In conclusion, no further additional hardware components other than those found in the respective independent claims are recited, thus it is presumed that the claims are further utilizing the same generic systemization as presented above. The dependent claims do not include any additional elements that integrate the abstract idea into a practical application of the exception or are sufficient to amount to significantly more than the judicial exception when considered both individually and as an ordered combination.
Therefore, the dependent claims are also directed to an abstract idea.
Thus, Claims 1-3, 5, 12-15, 17-20, 22, and 29-32 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Subject Matter Free of Prior Art
US PG Pub 2011/0251850 A1 as taught by Stephens discloses the dispensing machine provides for secure storage, convenient packaging, and accurate dispensing of prescription medications on schedule, "STAT"(immediately), or on demand (also referred to as "PRN" or as the resident or patient requests), automatically or under computer control, under the supervision or administration of a director of nursing in the typical facility (Stephens Para 57).
US PG Pub 2010/0030667 A1 as taught by Chudy discloses the storage locations are grouped into subsets based on storage location size and/or type and the storage location ease-of-accessibility rankings are determined within each subset. This embodiment accommodates containers having different sizes, such as small, medium, or large, and accommodates various types of storage such as drawer-type storage, refrigerated storage and controlled-access storage (Chudy Para 25)… The storage locations (e.g., locations 37-59) are organized in a hierarchy with each storage location having a ranking first-to-last based on the relative ease of access of each storage location to workstation 21. "Ease of access" means or refers to an assessment of the ease and/or efficiency with which a storage location is reached or accessed by pharmacy personnel. The assessment can be made based a variety of factors described herein. Such a ranking of the storage locations (e.g., locations 37-59) enables system 11 to direct storage of the containers (e.g., containers 13-19) for the most frequently-used pharmaceutical products to the storage locations (e.g., locations 37-59) most easily accessible to the workstation 21. [pharmaceutical product rankings together with ease of accessibility rankings is the degree of disruption] (Chudy Para 52) However, Chudy is disclosing various storage locations within one dispenser, not distributing pharmaceuticals to more than one dispenser.
KR20150042940A discloses an automatic preparation control step of controlling to perform the preparation of the prescription by the preparation device calculated the highest score [distributing according to result of score calculation] according to the efficiency among the provided recommended pharmaceutical preparation devices (KR ‘940 Para 18).
IN 2015/KON/03847 A as taught by Utech discloses the system evaluates retrospective item utilization data, present item utilization data [history data of dispensing], and predicted item utilization data [anticipation of needs] in order to automatically suggest and/or set item stock configuration levels using minimum intervention by a user. Para 27 discloses having received initial system parameters from a user for configuring the ADMs 1 10, the inventory management system 130 may then determine appropriate amounts of inventory of items for forward deployment to compartments in the ADMs 1 10 used as distributed stores (e.g., in patient care areas [physical location of users expected to need the pharmaceuticals]) (Utech Para 21).
While the above listed references list various embodiments related to pharmaceutical dispensing, there is no obvious combination of prior or nor is there a prior art reference that discloses that pharmaceuticals that are expected to be dispensed together are distributed to the same pharmaceutical dispensing machine albeit of their scoring wherein the scoring is a degree of expected disruption caused to a pharmaceutical dispensing schedule by dispensing thereof by said at least one first pharmaceutical dispensing machine. Therefore, independent claims 1 and 18 and dependent claims 2-3, 5, 12-15, 17, 19-20, 22, and 29-32 contain subject matter free of prior art.
Response to Arguments
Applicant’s arguments filed 09/15/2025 with respect to 35 U.S.C. § 112(a) have been fully considered, and are persuasive. Therefore, the previous 35 U.S.C. § 112(a) rejection has been withdrawn.
Applicant’s arguments filed 09/15/2025 with respect to 35 U.S.C. § 101 have been fully considered, but are not persuasive. Applicant argues that the claims are directed to a specific improvement in a technological process because the two class dispenser system is provisioned to reduce interruptions, fit the pharmaceutical in a limited capacity, and grouping co dispensed items so they are stored together. The Examiner respectfully disagrees. MPEP 2106.04(d)(1) and MPEP 2106.05(a) indicates that a practical application may be present where the claimed invention provides a technical solution to a technical problem. See, e.g., DDR Holdings, LLC. v. Hotels.com, L.P., 773 F.3d 1245, 1259 (Fed. Cir. 2014) (finding that claiming a website that retained the “look and feel” of a host webpage provided a technological solution to the problem of retention of website visitors by utilizing a website descriptor that emulated the “look and feel” of the host webpage, where the problem arose out of the internet and was thus a technical problem). Here, the Applicant’s argued problem is not a technological problem caused by the technological environment to which the claims are confined. The problem of schedule interruptions / disruptions and the need for grouping co-dispensed items together was not a problem caused by the physical dispensing machine that is involved in the process. At best, Applicant’s identified problem is a business problem. Because no technological problem is present, the claims do not provide a practical application.
Further, Applicant’s claimed invention recites the additional element(s) of a first and second pharmaceutical dispensing machine. There is no indication that these additional elements operate in a manner different than they normally operate. For example, displaying data on an external monitor does not improve the monitor. In this case, distributing pharmaceuticals to be dispensed to the pharmaceutical dispensing machines does not provide any improvement to the pharmaceutical dispensing machines. It is operating as it normally operates. Operating another device in the manner it normally operates is insufficient to improve that other technology. As such, these additional elements are not improved through implementation of the abstract idea and a practical application is not present.
Applicant’s arguments filed 09/15/2025 with respect to 35 U.S.C. § 103 have been fully considered, and are persuasive in light of the arguments again the Wang reference that was used to reject claims 4 and 21. Applicant rolled up claims 4 and 21 into the respective independent claims 1 and 18. As such, the previous 35 U.S.C. § 103 rejection has been withdrawn a “Subject Matter Free of Prior Art” section has been added above to describe in detail why the claims contain subject matter free of prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA J MORICE whose telephone number is (703)756-4608. The examiner can normally be reached M-F 8:30-5:30 pm.
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/SARA JESSICA MORICE DE VARGAS/Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681