Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Response to Amendment
In the response dated 09 March 2026, no amendments were presented.
Claims 1-3, 5-13, and 15-20 are pending.
Priority
This application claims priority to U.S. Provisional Patent Application No. 60/888,8320 dated 08 February 2007.
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, 5-13, and 15-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1 and 11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites a system and method for preparing and managing sterile compounded medication products prepared in anticipation of use at a remote location.
The limitations of (Claim 1 being representative)
determine availability data of the automated sterile compounding dose preparation station based on a current working status and a number of doing orders to be prepared by the automated sterile compounding dose preparation station;
transmit the availability data of the automated sterile compounding dose preparation station;
receive an inventory dose order that does not correspond to a patient when it is determined that the automated sterile compounding dose preparation station has availability based on the availability date, the inventory dose order specifying a sterile compounded medication product that is suitable for administration by intravenous introduction to a human;
[output instructions to] prepare an inventory dose corresponding to the inventory dose order, the inventory dose including the sterile compounded medication product that is suitable for administration by intravenous introduction to a human;
determine an expiration date of the inventory dose; and
[construct] an indication indicating that the inventory dose is to be stored and includes information indicative of the expiration date of the inventory dose
transmit an indication indicative that the inventory dose is prepared and staged for storage, and update a datastore of stored inventory doses to include the inventory dose order.
, as drafted, is a process that, under the broadest reasonable interpretation, covers performance of the limitation in the mind but for recitation of generic computer components. That is, other than reciting an automated sterile compounding dose preparation station, nothing in the claim precludes the step from practically being performed in the mind. For example, but for the automated sterile compounding dose preparation station, the claims encompass a person mentally determining compounding station availability, outputting instructions to prepare a compounded medication based on the availability, determining an expiration date of the medication, and outputting instructions to print a label, in the manner described in the identified abstract idea, supra. See also Decision on Appeal for Application No. 11/844,135 (parent application) dated 26 September 2019 at Pg. 10. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Alternately, the noted limitations, as drafted, is a process that, under the broadest reasonable interpretation, covers a method of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. That is, other than reciting an automated sterile compounding dose preparation station, the claimed invention amounts to managing personal behavior or interaction between people. For example, but for the automated sterile compounding dose preparation station, this claim encompasses a person determining compounding station availability, outputting instructions to prepare a compounded medication based on the availability, determining an expiration date of the medication, and outputting instructions to print a label, in the manner described in the identified abstract idea, supra. Applicant’s Specification indicates that associating and filling dose orders is a human activity (see Spec. Pg. 1-6). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “method of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional element of an automated sterile compounding dose preparation station that implements the identified abstract idea. The automated sterile compounding dose preparation station is not described by the applicant and is recited at a high-level of generality (i.e., a generic workstation) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The Examiner notes that workstations capable of automatically dispensing pharmaceuticals were generic items at the time of the invention as evidenced by Spec. Pg. 2, Lns. 7-14, Pg. 4, Ln. 23—Pg. 5, Ln. 6 and the prior art of record (see, e.g., U.S. 2002/0032582 to Freeney at Fig. 1, Abstract; US 2002/0198738 to Osborne at Abstract; US 2006/0136095 to Rob at Abstract, Para. 0031, 0042).
The claims further recite the additional elements of (1) a server having a database and connected by a network, (2) preparation of an inventory dose corresponding to the inventory dose order, and (3) cause a printer to print a label for the inventory dose. Regarding (1), the server having a database and connected by a network merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. Regarding (2) and (3), preparation of an inventory dose corresponding to the inventory dose order and printing of a label related to the prepared dose applies the results of the abstract idea (“apply it”). MPEP 2106.04(d)(I) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide a practical application. Accordingly, even in combination, this additional element does not integrate the abstract idea into a practical application.
The claim does 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 using an automated sterile compounding dose preparation station to perform the noted steps 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”).
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of (1) a server having a database and connected by a network, (2) preparation of an inventory dose corresponding to the inventory dose order, and (3) cause a printer to print a label for the inventory dose. Item (1) generally links while items (2) and (3) are “apply it.” MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more while MPEP2106.05(I)(A) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide an inventive concept (“significantly more”). Further, the Specification at Pg. 1-6 indicates that both automatically preparing a dose at/by a dose preparation station and printing a label on a printer were well-understood, routine, conventional activity in the field at the time of the invention. See also Decision on Appeal for Application No. 11/844,135 (parent application) dated 26 September 2019 at Pg. 17. As such the claim is not patent eligible.
Claims 2, 3, 5-10, 12, 13, and 15-20 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 as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Claim(s) 2, 12 merely describe(s) an intended result of the label printing (the additional element of a label being analyzed in the same manner as in Claims 1 and 11).
Claim(s) 3, 13 merely describe(s) the type of storage location.
Claims 3 and 13 further recite the additional element of a refrigerator or cabinet. These additional elements merely generally link the abstract idea to a particular technological environment or field of use which cannot provide a practical application or significantly more for the reasons noted supra. Claims 4 and 14 recite a database which is part of the server and does not provide a practical application or significantly more for the reasons noted with respect to claims 1 and 11.
Claim(s) 7, 17 merely describe(s) updating data. The Examiner notes that the functions of the server are not part of the claimed invention and are non-functional descriptive information; the claim is directed to the functions of the automated sterile compounding dose preparation station, not the server.
Claim(s) 5, 15 merely describe(s) the status of the inventory doses.
Claim(s) 6, 16 merely describe(s) the non-functional data on the label (the additional element of a label being analyzed in the same manner as in Claims 1 and 11).
Claim(s) 8, 18 merely describe(s) creating order data and transmitting it.
Claim(s) 9, 19 merely describe(s) what availability data includes.
Claim(s) 10, 20 merely describe(s) information about the dose.
Response to Arguments
Rejection under 35 U.S.C. § 101
Regarding the rejection of Claims 1-3, 5-13, and 15-20, the Examiner has considered the Applicant’s arguments; however, the arguments are not persuasive. Applicant argues:
Similar to BASCOM and Desjardins, independent Claims 1 and 11 recite a technology-based solution that, when the claim elements are combined, uses an automated sterile compounding dose preparation station to compound and prepare an inventory dose based on anticipated demand.
Regarding (a), the Examiner respectfully disagrees that Applicant’s claims are anything like the claims presented in BASCOM and Desjardins. Applicant’s claims are not locating a known element (a known filter) in a non-routine location as in BASCOM. Nor are the claims improving how machine learning operates as in Dejardens.
The claims, as a whole, provide a technology-based solution regarding a specific improvement over prior art systems by proactively preparing inventory medication doses based on anticipated demand.
Regarding (b), the Examiner respectfully disagrees. While the claimed invention may or may not provide a “technology-based solution,” the test the Examiner presumes that the Applicant’s is arguing is whether the claimed invention is providing an unconventional technological solution to a technological problem caused by the technological environment to which the claims are confined. See MPEP 2106.05(a). The Examiner cannot locate, nor the Applicant pointed to, any technological problem caused by the dose preparation station. All of the “problems” described by the Applicant are administrative problems related to pharmacies. Ex Parte Dejardens did not affect this analysis. A person having skill in the art would not recognize any of the “problems” presented in Applicant’s disclosure as technical problems.
The Examiner further notes that similar arguments were presented in the Appeal Brief for parent Applicant 11/884,135. PTAB found these arguments to be unpersuasive. See Application 11/844,135 Patent Board Decision dated 26 September 2016 staring at numbered Pg. 15.
Conclusion
THIS ACTION IS MADE FINAL. 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 JASON S TIEDEMAN whose telephone number is (571)272-4594. The examiner can normally be reached 7:00am-4:00pm, off alternate Fridays.
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/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683