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 .
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.
Claims 4, 6-11, 16, 21, 23-28 and 33-40 have been canceled.
Claims 1-3, 5, 12-15, 17-20, 22, and 29-32 have been rejected.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 5, 12-15, 17-20, 22, and 29-32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 18 have been newly amended to recite, “finding a subset of said non-scheduled pharmaceuticals which has a lower degree of expected disruption relative to non-selected non-scheduled pharmaceuticals based on said scoring.” Example 18 in the specification on page 5 discloses, “wherein said one or more non-scheduled pharmaceuticals included in said at least one second pharmaceutical dispensing machine reduce potential disruption in said pharmaceutical dispensing schedule in comparison to including said one or more non-scheduled pharmaceuticals.” Thus, the claim as amended seemingly recites the opposite of what is supported in the specification as the “subset of said non-scheduled pharmaceuticals which has a lower degree of expected disruption…” is distributed to the second pharmaceutical dispensing machine and not the first pharmaceutical dispensing machine that is running on the schedule.
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(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1 and 18 have been newly amended to recite, “finding a subset of said non-scheduled pharmaceuticals which has a lower degree of expected disruption relative to non-selected non-scheduled pharmaceuticals based on said scoring.” Example 18 in the specification on page 5 discloses, “wherein said one or more non-scheduled pharmaceuticals included in said at least one second pharmaceutical dispensing machine reduce potential disruption in said pharmaceutical dispensing schedule in comparison to including said one or more non-scheduled pharmaceuticals.” This is seemingly the opposite of what is now claimed as the “subset of said non-scheduled pharmaceuticals which has a lower degree of expected disruption…” is distributed to the second pharmaceutical dispensing machine. The amendment thus indicates that the non-selected non-scheduled pharmaceuticals are those with the highest degree of expected disruption. Thus, the non-scheduled pharmaceuticals with the highest degree of expected disruption to the pharmaceutical dispensing schedule are distributed to the first pharmaceutical dispensing machine which contains the pharmaceuticals according to a pharmaceutical dispensing schedule based on step a of claims 1 and 18. It is indefinite why the pharmaceuticals with the highest degree of expected disruption to the pharmaceutical dispensing schedule would be distributed to the pharmaceutical dispensing machine that is running on the dispensing schedule. Therefore, the method would be purposely causing the disruption of the schedule. The Examiner believes the Applicant meant to claim the opposite, in that those with the highest degree of expected disruption would be brought to the second pharmaceutical dispensing machine and therefore would reduce the expected disruption to the schedule implemented in the first dispensing machine. Appropriate correction is required.
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).
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; and distributing non-scheduled pharmaceuticals not included in said subset to said at least one first 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 to perform a 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; and distributing non-scheduled pharmaceuticals not included in said subset to said at least one first 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 has a lower degree of expected disruption relative to non-selected non-scheduled pharmaceuticals 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.
The examiner is interpreting the above bolded limitations as additional elements as further discussed below. The following 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 steps i and ii of claims 1 and 18 wherein a human could, to paraphrase, determine where to 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 4/21/2026 with respect to 35 U.S.C. § 112(b) have been fully considered, and are persuasive. Therefore, the previous 35 U.S.C. § 112(b) rejections have been withdrawn. However, in light of the amendments, new 35 U.S.C. § 112(a) and 35 U.S.C. § 112(b) rejections have been presented above.
Applicant’s arguments filed 4/21/2026 with respect to 35 U.S.C. § 101 have been fully considered.
The Applicant argues that the claims require physical acts that cannot be performed in the human mind, specifically, “physically distributing and storing said pharmaceuticals according to a result of said determining.” This argument is persuasive and as such the mental process grouping has been withdrawn for this specific limitation. However, the limitation still falls under certain methods of organizing human activity. As such, the claims are still ineligible under 35 U.S.C. § 101.
The Applicant argues that the scoring step of claim 1, “scoring each non-scheduled pharmaceutical by a degree of expected disruptions caused to said pharmaceutical dispensing schedule by dispensing thereof by said at least one first pharmaceutical dispensing machine,” is not a human mental evaluation. The Examiner respectfully disagrees. The scoring limitation describes a mental process wherein the human calculated a score “by a degree of expected disruption caused to said pharmaceutical dispensing schedule.” The Examiner notes that it is not claimed that the score is determined based on the machine’s, “current schedule state, batch queue, and operational parameters.” However, even if the claims did require that the score was based on these requirements, a person of ordinary skill in the art of stocking pharmaceutical machines would reasonably be able to calculate the score mentally based on knowledge of the current schedule of a machine, the batch queue, and the operational parameters of the machine.
Third, the Applicant argues that, “finding a subset of said non-scheduled pharmaceuticals which… also fits in said limited pharmaceutical storage capacity of said at least one second pharmaceutical dispensing machine,” discloses a concrete physical constraint. The Examiner respectfully disagrees. The limitation describes an evaluation and observation of the storage capacity of a pharmaceutical dispensing machine. A person of ordinary skill in the art of stocking pharmaceutical machines would reasonably be able to determine a subset of non-schedules pharmaceuticals that fits within the storage capacity of a pharmaceutical dispensing machine.
The Applicant then argues that the claims are not directed to certain methods of organizing human activity. The Examiner respectfully disagrees. MPEP 2106. 04(a)(2)(II) states that a claimed invention is directed to certain methods of organizing human activity if the identified claim elements contain limitations that encompass fundamental economic principles or practices, commercial or legal interactions, or managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). The Examiner submits that the identified claim elements represent a series of rules or instructions that a person or persons, with or without the aid of a computer, would follow to determine where pharmaceuticals should be stocked. Applicant has not pointed to anything in the claims that fall outside of this characterization. The claims and specification of the instant application do not identify a specific machine or technology that is doing the distributing of the pharmaceutical products between the two pharmaceutical dispensing machines. As such, the broadest reasonable interpretation of the claim is that it is describing the process a person or persons would use to determine where the pharmaceuticals should be stocked based on a score and subsequently distributing the pharmaceuticals to each dispensing machine after determining the score. Because the claim elements fall under a series of rules or instructions that a person or persons would follow to determine where pharmaceuticals should be stocked, the claimed invention is directed to an abstract idea.
Further, the Applicant argues that the claims solve a technical problem rooted in the physical dispensing system. 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 pharmaceutical dispensing machines or any computer like a processor or server (which the Examiner notes is not claimed). The problem of needing to respond to non-scheduled demands is not a problem caused by the pharmaceutical dispensing machines that are involved in the process. At best, Applicant’s identified problem is a business problem as discussed extensively in the interview conducted on March 26th, 2026. Because no technological problem is present, the claims do not provide a practical application.
Further, 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. The Examiner further notes that the claims do not even require the pharmaceutical dispensing machine to dispense any medicine. It merely recites the process of determining where to distribute pharmaceuticals for storing. Therefore, the pharmaceutical dispensing machine is storing pharmaceuticals as expected before potentially dispensing the pharmaceuticals.
The Applicant further argues that the examiner misapplies DDR Holdings. The Examiner respectfully disagrees. Please 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. The problem arose out of the internet and was thus a technical problem. The claims of the instant application recite determining where to distribute pharmaceuticals based on a calculated score wherein the problem of needing to respond to non-scheduled demands is not a problem caused by the pharmaceutical dispensing machines that are involved in the process. At best, Applicant’s identified problem is a business problem as presented above and therefore the claims of the instant application are not analogous to those discussed in DDR Holdings.
The Applicant argues that the claims recite a specific technical architecture and lists 6 components of the method. The Examiner notes that components 1-2 were found to be recited at a high-level of generality such that it amounts to no more than mere instructions to implement an abstract idea by adding the words ‘apply it’ (or an equivalent) with the judicial exception. Components 3-6 were found to be a part of the abstract idea as presented above and do not describe technical architecture, it merely recites the process of determining which pharmaceuticals to distribute where, wherein the two options are the two pharmaceutical dispensing machines that are behaving as expected (merely storing pharmaceuticals before a person needs them dispensed).
Further, MPEP 2106.05(I) states: “As made clear by the courts, the novelty of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter (internal quotations omitted, emphasis original).” As such, the Examiner’s finding that the claims contain subject matter free of prior art is of no relevance when determining whether the claims fall within the § 101 categories of possibly patentable subject matter. Further, there is no indication that these additional elements (the two pharmaceutical dispensing units) 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. The Examiner further notes that the claims do not even require the pharmaceutical dispensing machine to dispense any medicine. It merely recites the process of determining where to distribute pharmaceuticals for storing. Therefore, the pharmaceutical dispensing machine is storing pharmaceuticals as expected before potentially dispensing the pharmaceuticals.
Further, the Applicant argues that the Examiner’s reliance on Berkheimer is inapplicable. The Examiner respectfully disagrees. MPEP 2106.05(d) states: “Another consideration when determining whether a claim recites significantly more than a judicial exception is whether the additional element(s) are well-understood, routine, conventional activities previously known to the industry (emphasis added).” Further, MPEP 2106.05(I) states: “As made clear by the courts, the novelty of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter (internal quotations omitted, emphasis original).” As such, it is only the additional elements identified by the Examiner to not be part of the abstract idea that are analyzed to determine whether they represent well-understood, routine, conventional activities in the field of the invention.
In that regard, MPEP 2106.05(d)(I) indicates that in determining whether the additional elements represent well-understood, routine, conventional activities, the Examiner should consider whether the additional elements (1) provide an improvement to the technological environment to which the claim is confined, (2) whether the additional elements are mere instructions to apply the judicial exception, or (3) whether the additional elements represent insignificant extra-solution activity. The additional elements of the claims do not provide significantly more based on this inquiry.
The Examiner again notes that there is no specific hardware utilized to output the analysis of the claims. The only technology the claims recite are the two pharmaceutical dispensing units that were found to be recited at a high level of generality and has been found by the courts to be insufficient to provide a practical application (see MPEP 2106.05(d)(II); Alice Corp.). None of the additional elements of the claim were found to represent extra-solution activity and thus no-well-understood, routine, conventional analysis is required.
Next, the Applicant argues that the additional elements amount to significantly more. The Examiner respectfully disagrees. The additional elements of the claims are, “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.” The additional elements were found to be recited at a high-level of generality such that it amounts to no more than mere instructions to implement an abstract idea by adding the words ‘apply it’ (or an equivalent) with the judicial exception. MPEP 2106.05(I)(A) discloses that adding the words “apply it” (or an equivalent” with the judicial exception is not enough to qualify as “significantly more” when recited in a claim with a judicial exception. Further, 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. The Examiner further notes that the claims do not even require the pharmaceutical dispensing machine to dispense any medicine. It merely recites the process of determining where to distribute pharmaceuticals for storing. Therefore, the pharmaceutical dispensing machine is storing pharmaceuticals as expected before potentially dispensing the pharmaceuticals.
Finally, the Applicant further argues that the Examiner’s characterization of the machines as generic components is factually unsupported. The Examiner respectfully disagrees. The Applicant argues that “a machine that is configured to store, package, and dispense pharmaceuticals in batches according to a schedule is, by definition, an automated machine, not a human. Automated pharmaceutical dispensing machines necessarily include processors, sensors, and control systems to execute their configured functions. The scoring and subset-finding steps are performed in the context of and in service of the operation of these physical machines.” 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 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 (e.g., a human opening the machine and manually distributing the pharmaceuticals that were stored therein). The fact that a dispensing machine “has processors, sensors, and control systems to execute their configured functions,” does not clearly indicate that the scores are calculated by these processors, sensors, and control systems. The claim discloses, “the method comprising: a. distributing pharmaceuticals to be dispensed according to said 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… determining said subset by: i. scoring each non-scheduled pharmaceutical by a degree of expected disruption.” The claim does not disclose that the dispensing machines (the first or second one) are calculating the score itself, it merely discloses “a method of distributing pharmaceuticals in a pharmaceutical dispensing system,” wherein the system comprises the two different dispensing machines. Therefore, as previously presented, there is no disclosure of a machine (for example: a computer, a processor) that is determining the score of the pharmaceuticals. Further, 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. Determining which pharmaceutical dispensing machine to bring specific pharmaceuticals to based on a score for a non-scheduled pharmaceutical (based on a degree of expected disruption caused to a pharmaceutical dispensing schedule) describes certain methods of organizing human activity as it describes rules or instructions a person or persons would follow to distribute pharmaceuticals to a correct location based on a score.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter H. Choi can be reached on (469)295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARA JESSICA MORICE DE VARGAS/Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681
Prosecution Insights