DETAILED ACTION
Status of Claims
This is the first office action on the merits in response to the application filed on 5 August 2024 and the preliminary amendments filed 21 March 2025.
Claims 25-32 are new with the preliminary amendments.
Claim(s) 1-32 are currently pending and have been examined.
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 .
Priority
This application claims priority of US Provisional Application No. 62/754031 filed on 1 November 2018, PCT/US2019/59143 filed on 31 October 2019, and US Application No. 17/290823 filed on 3 May 2021. Applicant’s claim for the benefit of these prior filed applications are acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 26 March 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “rules engine” in claims 1 and 13.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112(b)
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 1-29 is/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 not listed below are rejected for dependency.
Claim 1 recites “a rules engine for determining the appropriateness of a medication vis-à-vis a medical condition of a patient.”
Claim limitation “rules engine” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
The disclosure indicates that a CPU performs the function of the means plus function element (See at least [0039] and [0055]). Note MPEP 2181, “For a computer-implemented 35 U.S.C. 112(f) claim limitation, the specification must disclose an algorithm for performing the claimed specific computer function, or else the claim is indefinite under 35 U.S.C. 112(b). “ Here, the disclosure does not appear to provide an algorithm for implementing the identified functionality. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Claim 13 is similarly rejected.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 12 and 24 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 12 recites wherein said database comprises at least one of a structured database and an unstructured database. These options, unstructured and structured, are collectively exhaustive of databases. As such, this limitation does not further limit the subject matter of the claim upon which it depends. Claim 24 is similarly rejected. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1, which is representative of claim 13, recites a system for automatically monitoring the delivery of medication to a patient, the system comprising:
a
a prescription order identifying a medication to be delivered to said patient;
The preceding recitation of the claim has had strikethroughs applied to the additional elements beyond the abstract idea to more clearly demonstrate the limitations setting forth the abstract idea. The remaining limitations describe a concept of evaluating and recording the appropriateness of a prescription order. This concept describes a mental process that a pharmacist should follow to resolve the appropriateness of a prescription order similar to the “mental process that a neurologist should follow when testing a patient for nervous system malfunctions” given in MPEP 2106.04(a)(2)(II)(C) as an example of managing personal behavior in the methods of organizing human activity sub-grouping. As such, these limitation set forth a method of organizing human activity. Therefore the claims are determined to recite an abstract idea.
MPEP 2106, reflecting the 2019 PEG, directs examiners at Step 2A Prong Two to consider whether the additional elements of the claims integrate a recited abstract idea into a practical application.
The claims recite the additional element of a system, the system comprising: an engine and a central processing unit (CPU. This additional element is recited at an extremely high level of generality, and is interpreted as a generic computing device used to implement the abstract idea. Per MPEP 2106.05(f), implementing an abstract idea on a generic computing device does not integrate an abstract idea into a practical application in Step 2A Prong Two, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea on a generic computer. As such, this additional element does not integrate the abstract idea into a practical application.
The claims further recite the additional element of electronic records and a database. This additional element reflects no improvement to technology. This additional elements does not require any particular machine. This additional elements does not effect a transformation of an article. And this additional element does not meaningfully limit the implementation of the abstract idea. Instead, this additional element only generally links the abstract idea to a technological environment of a computing device. As such, this additional element does not integrate the abstract idea into a practical application.
There are no further additional elements. When considered as a combination, the additional elements only generally link the abstract idea to a technological environment of a computing device. Therefore the combination of additional elements does not integrate the abstract idea into a practical application. Because the additional elements, individually and as a combination, fail to integrate the claims into a practical application the claims are determined to be directed to an abstract idea.
At Step 2B of the Mayo/Alice analysis, examiners are to consider whether the additional elements amount to significantly more than the abstract idea.
As previously noted, the claims recite an additional element which may be interpreted as a generic computing device used to implement the abstract idea. However, per MPEP 2106.05(f), implementing an abstract idea on a generic computing device does not add significantly more in Step 2B, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea on a generic computer. As such, this additional element does not amount to significantly more.
As previously noted, the claims recite the additional element of electronic records and a database. However, per MPEP 2106.05(d)(II), storing information in memory is a well-understood, routine, and conventional computer function. As such, this additional element, individually and in combination with the computing device additional element, does not amount to significantly more than the abstract idea. Therefore, when considered individually and as a combination, the additional elements of claims 1 and 13 do not amount to significantly more than the judicial exception. Thus claims 1 and 13 are not patent eligible.
Dependent claims 2-11, 14-23, and 25-29 further narrow the abstract idea of claims 1 and 13, but these claims continue to recite abstract ideas, albeit narrowed ones. Dependent claims 2-11 and 14-23 recite no further additional elements. The previously identified additional elements, individually and as a combination, do not integrate the narrowed abstract ideas into practical applications for the same reasons as indicated above. As such, claims 2-11 and 14-23 are also directed to abstract ideas. At Step 2B, the previously identified additional elements, individually and as a combination, do not amount to significantly more than the narrowed abstract ideas for the same reasons as indicated above. As such, the additional elements of these claims do not amount to significantly more than the narrowed abstract ideas. Dependent claim 12 and 24 does not further limit the claims and thus the above rejection for the independent claim is also applicable to these claims. Dependent claims 25-29 further recites the additional element of a user interface. This additional element, when considered either individually or in combination with the previously identified additional elements, only generally links the narrowed abstract ideas to a technological environment of a computing device. As such, claims 25-29 are also directed to abstract ideas. At Step 2B, the previously identified additional elements, individually and as a combination, only generally links the narrowed abstract ideas to a technological environment of a computing device. As such, the additional elements of these claims do not amount to significantly more than the narrowed abstract ideas. Because dependent claims 2-12 and 14-29 remain directed to an abstract idea without reciting significantly more, dependent claims 2-12 and 14-29 are not patent eligible.
Claim 30 recites a method for automatically monitoring the delivery of medication to a patient, the method comprising:
providing a system comprising: a prescription order identifying a medication to be delivered to a patient;
determining the appropriateness of the prescription order vis-à-vis the current medical condition of the patient;
displaying the appropriateness of a prescription order to a user
automatically monitoring the
after each change in the medical condition of the patient, re-determining the appropriateness of the prescription order vis-à-vis the current medical condition of the patient; and
The preceding recitation of the claim has had strikethroughs applied to the additional elements beyond the abstract idea to more clearly demonstrate the limitations setting forth the abstract idea. The remaining limitations describe a concept of monitoring, evaluating, recording the appropriateness of a prescription order. This concept describes a mental process that a pharmacist should follow to repeatedly resolve the appropriateness of a prescription order similar to the “mental process that a neurologist should follow when testing a patient for nervous system malfunctions” given in MPEP 2106.04(a)(2)(II)(C) as an example of managing personal behavior in the methods of organizing human activity sub-grouping. As such, these limitation set forth a method of organizing human activity. Therefore the claim is determined to recite an abstract idea.
MPEP 2106, reflecting the 2019 PEG, directs examiners at Step 2A Prong Two to consider whether the additional elements of the claims integrate a recited abstract idea into a practical application.
The claim recites the additional element of electronic records and a database. This additional element reflects no improvement to technology. This additional elements does not require any particular machine. This additional elements does not effect a transformation of an article. And this additional element does not meaningfully limit the implementation of the abstract idea. Instead, this additional element only generally links the abstract idea to a technological environment of a computing device. As such, this additional element does not integrate the abstract idea into a practical application.
The claims further recite the additional element of a user interface and modifying the user interface. This additional element reflects no improvement to technology. This additional elements does not require any particular machine. This additional elements does not effect a transformation of an article. And this additional element does not meaningfully limit the implementation of the abstract idea. Instead, this additional element only generally links the abstract idea to a technological environment of a computing device. As such, this additional element does not integrate the abstract idea into a practical application.
There are no further additional elements. When considered as a combination, the additional elements only generally link the abstract idea to a technological environment of a computing device. Therefore the combination of additional elements does not integrate the abstract idea into a practical application. Because the additional elements, individually and as a combination, fail to integrate the claims into a practical application the claims are determined to be directed to an abstract idea.
At Step 2B of the Mayo/Alice analysis, examiners are to consider whether the additional elements amount to significantly more than the abstract idea.
As previously noted, the claims recite the additional element of electronic records and a database. However, per MPEP 2106.05(d)(II), storing information in memory is a well-understood, routine, and conventional computer function. As such, this additional element does not amount to significantly more than the abstract idea.
The claim further recites the additional element of a user interface and modifying the user interface. However Keys et al. (US 2001/0050681 A1) demonstrates (See at least [0026]) that user interfaces were conventional long before the priority date of the claimed invention. As such, this additional element does not amount to significantly more than the abstract idea.
There are no further additional elements. When considered as a combination, the additional elements only generally link the abstract idea to a technological environment of a computing device. Therefore the combination of additional elements does not amount to significantly more than the abstract idea. Therefore, when considered individually and as a combination, the additional elements of claim 30 do not amount to significantly more than the judicial exception. Thus claim 30 is not patent eligible.
Dependent claims 31 and 32 further narrow the abstract idea of claim 30, but these claims continue to recite abstract ideas, albeit narrowed ones. Dependent claims 31 and 32 recite no further additional elements. The previously identified additional elements, individually and as a combination, do not integrate the narrowed abstract ideas into practical applications for the same reasons as indicated above. As such, claims 31 and 32 are also directed to abstract ideas. At Step 2B, the previously identified additional elements, individually and as a combination, do not amount to significantly more than the narrowed abstract ideas for the same reasons as indicated above. Because dependent claims 31 and 32 remain directed to an abstract idea without reciting significantly more, dependent claims 31 and 32 are not patent eligible.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 6-15, and 18-25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Silver (US 2009/0210252 A1).
Regarding claim 1 and 13: Silver discloses a system for automatically monitoring the delivery of medication to a patient, the system comprising:
an electronic medical record containing information regarding the medical condition of said patient (When a new order is placed 207, part of the analysis involves retrieving the patient's/resident's medical history through information already stored in the analysis unit 107. Clinical laboratory tests previously performed on the patient/resident are stored in -the analysis unit 107 at the time the tests were performed. Substantive information relating to the clinical test, including the results of the test are stored in the analysis unit 107 in such a way that the substantive information is available to the analysis unit 107 when analyzing a new order 207. See at least [0050]).
a prescription order identifying a medication to be delivered to said patient (When it is determined that a new order 103 for a medication is indicated, the order 103 is written and/or entered into a computer system via a suitable interface. As part of the order entry, the order is translated 105 and the substantive aspects of the order are extracted and translated into a standardized or proprietary format for entry into system for analysis 107. Substantive information contained in the medication order 103 may include: date of the order, patient/resident name and demographic information patient/resident ID number, healthcare facility, drug name, dosage and form (eg. tablet, liquid, intravenous (IV)). After translation 105, the substantive information is stored in an analysis unit 107 which may be a database or the like. See at least [0037]).
a database identifying contraindications and warnings for specific medications (Resources 111 other than the substantive information derived from entered orders 103 provide additional input to the analysis system 107. With respect to medications, additional resources 111 such as side effects, clinical indications, dosages, and interactions may be included in the analysis unit 107 and made available for analysis of incoming orders 103. See at least [0038]. Also: if the medication ordered is contra-indicated. See at least [0012]).
a rules engine for determining the appropriateness of a medication via-à-vis a medical condition of a patient (analysis unit. See at least [0038]); and
a central processing unit (CPU) (computer system. See at least [0037]) configured to (i) provide said prescription order and said electronic medical record of said patient to said rules engine, (ii) receive a determination from said rules engine regarding the appropriateness of said prescription order vis-à-vis said medical condition of said patient, and (iii) mark said electronic medical record with an indication regarding the appropriateness of said prescription order vis-à-vis said medical condition of said patient (When a new order 103 is placed, the substantive information relating to the order is stored in a database in the analysis unit 107. Analysis is performed based on the substantive information from the order to provide real-time feedback based on the available resources 111 also historical healthcare information stored in the database in the analysis unit 107. The medication order 103 is compared to clinical results and basic medical knowledge available to the analysis unit 107 and the appropriateness of the prescribed treatment is determined. See at least [0038]. Also: When an issue is detected with an order 301, 303, the central repository 307 is configured to notify the healthcare providers of the detected issue 311. Such notification may be in the form of a generated report 309 or a direct communication 311 to a healthcare provider in the form of an electronic message or the like. See at least [0055]. Also: Referring to FIG. 6, a sample report is shown indicating medications that may not be appropriate for the diagnosis provided in the order. See at least [0062]. Also: Other information relating to a patient, such as a potentially harmful drug interactions may be identified because healthcare information from the patient's/resident's previous medication orders 103 has been stored in the analysis unit 107 and are available for analysis when a new order 103 is placed. See at least [0040]).
Regarding Claim 2 and 14: Silver discloses the above limitations. Silver further discloses wherein said indication marked in said electronic medical record comprises at last one from the group consisting of a “proceed” indication, a “caution” indication and a “stop” indication (Referring to FIG. 6, a sample report is shown indicating medications that may not be appropriate for the diagnosis provided in the order. Medications may be grouped according to a diagnosis provided with the order. For some diagnoses 603, however, certain medications may be inappropriate or unnecessary. Using the data repository, a patient's/resident's 601 medications 605 may be compared to the diagnoses 603 to determine their appropriateness. When a medication 605 is associated with a diagnosis 603 that is not consistent with the medication ordered 605 it is included in the report. See at least [0062]. Also: If the dosage prescribed in the current new order 207 seems inappropriate based on analysis, a suggestion may be made to the healthcare provider who may then consider revising the order. See at least [0050]).
Regarding Claim 3 and 15: Silver discloses the above limitations. Silver further discloses wherein said indication marked in said electronic medical record comprises at last one of a “caution” indication and a “stop” indication, said system also provides explanatory information (Referring to FIG. 6, a sample report is shown indicating medications that may not be appropriate for the diagnosis provided in the order. Medications may be grouped according to a diagnosis provided with the order. For some diagnoses 603, however, certain medications may be inappropriate or unnecessary. Using the data repository, a patient's/resident's 601 medications 605 may be compared to the diagnoses 603 to determine their appropriateness. When a medication 605 is associated with a diagnosis 603 that is not consistent with the medication ordered 605 it is included in the report. See at least [0062]. Also: If the dosage prescribed in the current new order 207 seems inappropriate based on analysis, a suggestion may be made to the healthcare provider who may then consider revising the order. See at least [0050]).
Regarding Claim 6 and 18: Silver discloses the above limitations. Silver further discloses wherein said indication marked in said electronic medical record comprises a flag (Referring to FIG. 6, a sample report is shown indicating medications that may not be appropriate for the diagnosis provided in the order. Medications may be grouped according to a diagnosis provided with the order. For some diagnoses 603, however, certain medications may be inappropriate or unnecessary. Using the data repository, a patient's/resident's 601 medications 605 may be compared to the diagnoses 603 to determine their appropriateness. When a medication 605 is associated with a diagnosis 603 that is not consistent with the medication ordered 605 it is included in the report. See at least [0062]. Also: If the dosage prescribed in the current new order 207 seems inappropriate based on analysis, a suggestion may be made to the healthcare provider who may then consider revising the order. See at least [0050]. Also: Other information relating to a patient, such as a potentially harmful drug interactions may be identified because healthcare information from the patient's/resident's previous medication orders 103 has been stored in the analysis unit 107 and are available for analysis when a new order 103 is placed. See at least [0040]).
Regarding Claim 7 and 19: Silver discloses the above limitations. The limitation wherein said flag comprises a visual indicator is a description of information content. Here, the particular form of the flag does not perform or effect any function with respect to the system, and as such there is no functional relationship between the descriptive matter and the system. As such, this limitation is given limited patentable weight, and Silver is determined to continue to disclose the claimed invention.
Regarding Claim 8 and 20: Silver discloses the above limitations. The limitation wherein said visual indicator comprises at least one color selected from the group consisting of green, yellow, and red is a description of information content. Here, the particular form of the visual indicator does not perform or effect any function with respect to the system, and as such there is no functional relationship between the descriptive matter and the system. As such, this limitation is given limited patentable weight, and Silver is determined to continue to disclose the claimed invention.
Regarding Claim 9 and 21: Silver discloses the above limitations. The limitation wherein said visual indicator comprises at least one shape selected from the group consisting of a box, a triangle, and a circle is a description of information content. Here, the particular form of the visual indicator does not perform or effect any function with respect to the system, and as such there is no functional relationship between the descriptive matter and the system. As such, this limitation is given limited patentable weight, and Silver is determined to continue to disclose the claimed invention.
Regarding Claim 10 and 22: Silver discloses the above limitations. The limitation wherein said flag comprises an audible indicator is a description of information content. Here, the particular form of the flag does not perform or effect any function with respect to the system, and as such there is no functional relationship between the descriptive matter and the system. As such, this limitation is given limited patentable weight, and Silver is determined to continue to disclose the claimed invention.
Regarding Claim 11 and 23: Silver discloses the above limitations. Silver further discloses wherein said prescription order further comprises at least one of a dosage and a delivery schedule (When it is determined that a new order 103 for a medication is indicated, the order 103 is written and/or entered into a computer system via a suitable interface. As part of the order entry, the order is translated 105 and the substantive aspects of the order are extracted and translated into a standardized or proprietary format for entry into system for analysis 107. Substantive information contained in the medication order 103 may include: date of the order, patient/resident name and demographic information patient/resident ID number, healthcare facility, drug name, dosage and form (eg. tablet, liquid, intravenous (IV)). After translation 105, the substantive information is stored in an analysis unit 107 which may be a database or the like. See at least [0037]).
Regarding Claim 12 and 24: Silver discloses the above limitations. The claim limitation wherein said database comprises at least one of a structured database and an unstructured database does not actually further limit the claim. As such, Silver continues to disclose the claimed invention.
Regarding Claim 25: Silver discloses the above limitations. Silver further discloses a user interface for displaying the appropriateness of a prescription order to a user (When an issue is detected with an order 301, 303, the central repository 307 is configured to notify the healthcare providers of the detected issue 311. Such notification may be in the form of a generated report 309 or a direct communication 311 to a healthcare provider in the form of an electronic message or the like. See at least [0055]. Also: Referring to FIG. 6, a sample report is shown indicating medications that may not be appropriate for the diagnosis provided in the order. See at least [0062]. Also: The reports 117 may be delivered electronically, such as on a computer display, or may be generated into a computer file that may be downloaded or e-mailed. See at least [0043]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 4, 5, 16, 17, 26, 27, and 30-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Silver (US 2009/0210252 A1) in view of Narayan (US 2009/0177493 A1).
Regarding Claim 4 and 16: Silver discloses the above limitations. Silver does not expressly disclose wherein said central processing unit updates its function when there is a change in said electronic medical record. However, Narayan teaches wherein a central processing unit updates its function when there is a change in an electronic medical record (At step 605, the patient status reflecting the state of problem of a patient is monitored. This can be done manually by a clinician or automatically by a patient monitor. The patient status may be checked continuously or in a predefined interval. At step 610, a check is made to detect a change in patient status. If no change is detected the patient status will continued to be monitored as at step 605. If a change in patient status is detected the electronic medical record is updated with the patient status as at step 615. At step 620 a check is made to determine whether any corresponding medications related to the changed patient status exists in the electronic medical record. See at least [0037]. Also: an embodiment the invention provides a method and system for maintaining an electronic medical record. The electronic medical record is stored with patient status along with corresponding medications. A map is created linking the patient status with the medication such that a change in one parameter will automatically update the other related parameters in the electronic medical record. See at least [0023]).
Silver provides a system which evaluates the appropriateness of a medication for a treatment, upon which the claimed invention’s updating of this appropriateness after changes in the condition of the patient can be seen as an improvement. However, Narayan demonstrates that the prior art already knew of automatic updating of medication information based on a change in a patient’s status. One of ordinary skill in the art could have trivially applied Narayan’s updating techniques based on changes to a patient condition to the appropriateness determinations of Silver to arrive at a system which would update appropriateness on based on changes to a patient condition. Further, one of ordinary skill in the art would have recognized that such an application of Narayan would have resulted in an improved system which would provide users with the most up to date appropriateness determinations possible. As such, the application of Narayan, and the claimed invention, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in view of the disclosures of Silver and the teachings of Narayan.
Regarding Claim 5 and 17: Silver discloses the above limitations. Silver does not expressly disclose wherein said central processing unit updates its function when there is a change in at least one of said electronic medical record, said database and said rules engine. However, Narayan teaches wherein a central processing unit updates its function when there is a change in an electronic medical record, a database, and a rules engine (At step 605, the patient status reflecting the state of problem of a patient is monitored. This can be done manually by a clinician or automatically by a patient monitor. The patient status may be checked continuously or in a predefined interval. At step 610, a check is made to detect a change in patient status. If no change is detected the patient status will continued to be monitored as at step 605. If a change in patient status is detected the electronic medical record is updated with the patient status as at step 615. At step 620 a check is made to determine whether any corresponding medications related to the changed patient status exists in the electronic medical record. See at least [0037]. Also: an embodiment the invention provides a method and system for maintaining an electronic medical record. The electronic medical record is stored with patient status along with corresponding medications. A map is created linking the patient status with the medication such that a change in one parameter will automatically update the other related parameters in the electronic medical record. See at least [0023]).
Silver provides a system which evaluates the appropriateness of a medication for a treatment, upon which the claimed invention’s updating of this appropriateness after changes in the condition of the patient can be seen as an improvement. However, Narayan demonstrates that the prior art already knew of automatic updating of medication information based on a change in a patient’s status. One of ordinary skill in the art could have trivially applied Narayan’s updating techniques based on changes to a patient condition to the appropriateness determinations of Silver to arrive at a system which would update appropriateness on based on changes to a patient condition. Further, one of ordinary skill in the art would have recognized that such an application of Narayan would have resulted in an improved system which would provide users with the most up to date appropriateness determinations possible. As such, the application of Narayan, and the claimed invention, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in view of the disclosures of Silver and the teachings of Narayan.
Regarding Claim 26: Silver discloses the above limitations. Silver further discloses (i) monitor the electronic medical record of the patient for a change in the medical condition of the patient; (ii) re-determine the appropriateness of the prescription order vis-à-vis the current medical condition of the patient; and (iii) modify the user interface to display the re-determined appropriateness of the prescription order to the user (With regard to blood thinning therapies, medications are given to certain patients at risk for clots that may travel through the blood stream and block vital arteries. Blood clotting times are closely monitored on patients undergoing blood thinning therapies and a historical record of blood tests are analyzed to maintain proper dosing. Similarly, treatments for anemia require close and ongoing monitoring of patients' hemoglobin levels to determine the appropriateness of the treatment and the patient's/resident's ongoing need for treatment. See at least [0005]. Also: Real-time reporting 117 is made possible through analysis 107 because all of the past and present medical information for the patient/resident are available to the analysis unit 107 at the time the order is entered or the request for information is made. When an inquiry is made, either through the entry of a new order 103 or through an ongoing treatment 101 request for information, information relating to the patient, including medications and clinical test results are available for compilation and display. See at least [0043]. Also: if a patient/resident is under a course of treatment for anemia, and is being prescribed Procrit.RTM., when a new order is placed for Procrit.RTM., the patients past medical information stored in the analysis unit 107 includes previous orders for Procrit.RTM. as well as previous clinical test results for the patient's/resident's hemoglobin and hematocrit (H & H) levels. The currently ordered dosage may be compared to prior dosages and their associated clinical laboratory test results at the time the prior dosages were given. The patient's/resident's previous H & H levels may provide an indication that the current dosage is too low, or that H & H levels may indicate that the Procrit.RTM. dosage may be reduced. If the dosage prescribed in the current new order 207 seems inappropriate based on analysis, a suggestion may be made to the healthcare provider who may then consider revising the order. See at least [0050]).
Silver does not expressly disclose re-determining appropriateness after each change in the medical condition of the patient.
Narayan teaches updating information regarding medication after each change in the medical condition of a patient (At step 605, the patient status reflecting the state of problem of a patient is monitored. This can be done manually by a clinician or automatically by a patient monitor. The patient status may be checked continuously or in a predefined interval. At step 610, a check is made to detect a change in patient status. If no change is detected the patient status will continued to be monitored as at step 605. If a change in patient status is detected the electronic medical record is updated with the patient status as at step 615. At step 620 a check is made to determine whether any corresponding medications related to the changed patient status exists in the electronic medical record. See at least [0037]. Also: an embodiment the invention provides a method and system for maintaining an electronic medical record. The electronic medical record is stored with patient status along with corresponding medications. A map is created linking the patient status with the medication such that a change in one parameter will automatically update the other related parameters in the electronic medical record. See at least [0023]).
Silver provides a system which evaluates the appropriateness of a medication for a treatment, upon which the claimed invention’s updating of this appropriateness after changes in the condition of the patient can be seen as an improvement. However, Narayan demonstrates that the prior art already knew of automatic updating of medication information based on a change in a patient’s status. One of ordinary skill in the art could have trivially applied Narayan’s updating techniques based on changes to a patient condition to the appropriateness determinations of Silver to arrive at a system which would update appropriateness on based on changes to a patient condition. Further, one of ordinary skill in the art would have recognized that such an application of Narayan would have resulted in an improved system which would provide users with the most up to date appropriateness determinations possible. As such, the application of Narayan, and the claimed invention, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in view of the disclosures of Silver and the teachings of Narayan.
Regarding claim 27: Silver in view of Narayan makes obvious the above limitations. Silver further discloses update the electronic medical record to indicate the re-determined appropriateness of the prescription order (The patient's/resident's previous H & H levels may provide an indication that the current dosage is too low, or that H & H levels may indicate that the Procrit.RTM. dosage may be reduced. If the dosage prescribed in the current new order 207 seems inappropriate based on analysis, a suggestion may be made to the healthcare provider who may then consider revising the order. See at least [0050]. Also: Other information relating to a patient, such as a potentially harmful drug interactions may be identified because healthcare information from the patient's/resident's previous medication orders 103 has been stored in the analysis unit 107 and are available for analysis when a new order 103 is placed. See at least [0040]).
Regarding claim 30: Silver discloses a method for automatically monitoring the delivery of medication to a patient, the method comprising:
providing a system comprising: a prescription order identifying a medication to be delivered to a patient; a database identifying contradictions and warnings for specific medications; an electronic medical record containing information regarding the medical condition of the patient (When it is determined that a new order 103 for a medication is indicated, the order 103 is written and/or entered into a computer system via a suitable interface. As part of the order entry, the order is translated 105 and the substantive aspects of the order are extracted and translated into a standardized or proprietary format for entry into system for analysis 107. Substantive information contained in the medication order 103 may include: date of the order, patient/resident name and demographic information patient/resident ID number, healthcare facility, drug name, dosage and form (eg. tablet, liquid, intravenous (IV)). After translation 105, the substantive information is stored in an analysis unit 107 which may be a database or the like. See at least [0037]. Also: Resources 111 other than the substantive information derived from entered orders 103 provide additional input to the analysis system 107. With respect to medications, additional resources 111 such as side effects, clinical indications, dosages, and interactions may be included in the analysis unit 107 and made available for analysis of incoming orders 103. See at least [0038]. Also: if the medication ordered is contra-indicated. See at least [0012]. Also: When a new order is placed 207, part of the analysis involves retrieving the patient's/resident's medical history through information already stored in the analysis unit 107. Clinical laboratory tests previously performed on the patient/resident are stored in -the analysis unit 107 at the time the tests were performed. Substantive information relating to the clinical test, including the results of the test are stored in the analysis unit 107 in such a way that the substantive information is available to the analysis unit 107 when analyzing a new order 207. See at least [0050]).
determining the appropriateness of the prescription order vis-à-vis the current medical condition of the patient (When a new order 103 is placed, the substantive information relating to the order is stored in a database in the analysis unit 107. Analysis is performed based on the substantive information from the order to provide real-time feedback based on the available resources 111 also historical healthcare information stored in the database in the analysis unit 107. The medication order 103 is compared to clinical results and basic medical knowledge available to the analysis unit 107 and the appropriateness of the prescribed treatment is determined. See at least [0038]).
displaying the appropriateness of a prescription order to a user on a user interface (When an issue is detected with an order 301, 303, the central repository 307 is configured to notify the healthcare providers of the detected issue 311. Such notification may be in the form of a generated report 309 or a direct communication 311 to a healthcare provider in the form of an electronic message or the like. See at least [0055]. Also: Referring to FIG. 6, a sample report is shown indicating medications that may not be appropriate for the diagnosis provided in the order. See at least [0062]. Also: The reports 117 may be delivered electronically, such as on a computer display, or may be generated into a computer file that may be downloaded or e-mailed. See at least [0043]).
automatically monitoring the electronic medical record of the patient for a change in the medical condition of the patient; re-determining the appropriateness of the prescription order vis-à-vis the current medical condition of the patient; and modifying the user interface to display the re-determined appropriateness of the prescription order to the user (With regard to blood thinning therapies, medications are given to certain patients at risk for clots that may travel through the blood stream and block vital arteries. Blood clotting times are closely monitored on patients undergoing blood thinning therapies and a historical record of blood tests are analyzed to maintain proper dosing. Similarly, treatments for anemia require close and ongoing monitoring of patients' hemoglobin levels to determine the appropriateness of the treatment and the patient's/resident's ongoing need for treatment. See at least [0005]. Also: Real-time reporting 117 is made possible through analysis 107 because all of the past and present medical information for the patient/resident are available to the analysis unit 107 at the time the order is entered or the request for information is made. When an inquiry is made, either through the entry of a new order 103 or through an ongoing treatment 101 request for information, information relating to the patient, including medications and clinical test results are available for compilation and display. See at least [0043]. Also: if a patient/resident is under a course of treatment for anemia, and is being prescribed Procrit.RTM., when a new order is placed for Procrit.RTM., the patients past medical information stored in the analysis unit 107 includes previous orders for Procrit.RTM. as well as previous clinical test results for the patient's/resident's hemoglobin and hematocrit (H & H) levels. The currently ordered dosage may be compared to prior dosages and their associated clinical laboratory test results at the time the prior dosages were given. The patient's/resident's previous H & H levels may provide an indication that the current dosage is too low, or that H & H levels may indicate that the Procrit.RTM. dosage may be reduced. If the dosage prescribed in the current new order 207 seems inappropriate based on analysis, a suggestion may be made to the healthcare provider who may then consider revising the order. See at least [0050]).
Silver does not expressly disclose re-determining appropriateness after each change in the medical condition of the patient.
Narayan teaches updating information regarding medication after each change in the medical condition of a patient (At step 605, the patient status reflecting the state of problem of a patient is monitored. This can be done manually by a clinician or automatically by a patient monitor. The patient status may be checked continuously or in a predefined interval. At step 610, a check is made to detect a change in patient status. If no change is detected the patient status will continued to be monitored as at step 605. If a change in patient status is detected the electronic medical record is updated with the patient status as at step 615. At step 620 a check is made to determine whether any corresponding medications related to the changed patient status exists in the electronic medical record. See at least [0037]. Also: an embodiment the invention provides a method and system for maintaining an electronic medical record. The electronic medical record is stored with patient status along with corresponding medications. A map is created linking the patient status with the medication such that a change in one parameter will automatically update the other related parameters in the electronic medical record. See at least [0023]).
Silver provides a system which evaluates the appropriateness of a medication for a treatment, upon which the claimed invention’s updating of this appropriateness after changes in the condition of the patient can be seen as an improvement. However, Narayan demonstrates that the prior art already knew of automatic updating of medication information based on a change in a patient’s status. One of ordinary skill in the art could have trivially applied Narayan’s updating techniques based on changes to a patient condition to the appropriateness determinations of Silver to arrive at a system which would update appropriateness on based on changes to a patient condition. Further, one of ordinary skill in the art would have recognized that such an application of Narayan would have resulted in an improved system which would provide users with the most up to date appropriateness determinations possible. As such, the application of Narayan, and the claimed invention, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in view of the disclosures of Silver and the teachings of Narayan.
Regarding claim 31: Silver in view of Narayan makes obvious the above limitations. Per MPEP 2111.04, “The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met.” The claim describes steps that the method further comprises “if the prescription order is determined to be inappropriate.” The claim does not require the determination that the order is inappropriate, and as such the steps of this claim are not required by the broadest reasonable interpretation of the method. Thus Silver and Narayan continue to make obvious this claim.
Regarding claim 32: Silver in view of Narayan makes obvious the above limitations. Per MPEP 2111.04, “The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met.” The claim describes steps that the method further comprises “if the prescription order is determined to be inappropriate, and the medical staff does not provide at least one of (i), (ii), or (iii).” The claim does not require the determination that the order is inappropriate and that the medical staff does not provide the identified elements, and as such the steps of this claim are not required by the broadest reasonable interpretation of the method. Thus Silver and Narayan continue to make obvious this claim.
Claim(s) 28 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Silver (US 2009/0210252 A1) in view of Narayan (US 2009/0177493 A1), and further in view of Vaidya et al. (US 2013/0211847 A1).
Regarding claim 28: Silver in view of Narayan makes obvious the above limitations. Silver does not expressly disclose wherein if the prescription order is determined to be inappropriate, the CPU is configured to obtain at least one of the following from a medical staff before a medication can be delivered to the patient: (i) acknowledgement of the determination that the prescription order is inappropriate, (ii) a reason to continue delivery of the medication to the patient, and (iii) an override of the determination that the prescription order is inappropriate.
Vaidya teaches wherein if the prescription is determined to be inappropriate, the CPU is configured to obtain at least one of the following from a medical staff before a medication can be delivered to the patient: (i) acknowledgement of the determination that the prescription order is inappropriate, (ii) a reason to continue delivery of the medication to the patient, and (iii) an override of the determination that the prescription order is inappropriate (when an ordered prescription dosage exceeds a dosage that triggers a soft stop alert and a dosage that triggers a hard stop alert, the caregiver alone cannot override the hard stop alert. The hard stop alert can only be overridden after the caregiver consultants with a pharmacist who can then override the hard stop alert. See at least [0045]).
Silver and Narayan suggest a system which evaluates the appropriateness of a medication for a treatment, upon which the claimed invention’s acquiring of an override for an inappropriate prescription can be seen as an improvement. However, Vaidya demonstrates that the prior art already knew of acquiring of an override before providing a prescription automatically determined to be inappropriate. One of ordinary skill in the art could have trivially applied the techniques of Vaidya to the system of Silver and Narayan. Further, one of ordinary skill in the art would have recognized that such an application of Vaidya would have resulted in an improved system which would not provide prescriptions to patients when those prescriptions are determined to be inappropriate. As such, the application of Vaidya, and the claimed invention, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in view of the disclosures of Silver and the teachings of Narayan and Vaidya.
Regarding claim 29: Silver in view of Narayan and Vaidya makes obvious the above limitations. Vaidya further teaches wherein if the prescription order is determined to be inappropriate, and the medical staff does not provide at least one of (i), (ii) or (iii), the CPU is configured to modify the user interface to indicate that delivery of the medication to the patient is suspended (when an ordered prescription dosage exceeds a hard stop maximum dosage, the system issues a hard stop alert preventing the order from being filled.. See at least [0043]). The motivation to combine Silver, Narayan, and Vaidya is the same as explained under claim 29 above, and is incorporated herein.
Additional Considerations
The prior art made of record and not relied upon that is considered pertinent to applicant’s disclosure can be found in the PTO-892 Notice of References Cited.
Shiloh (US 2015/0058039 A1), Wager et al. (US 2016/0188844 A1), and Kamen (US 2011/0313789 A1) provide further relevant examples of systems which determine prescription appropriateness based on an electronic medical record.
Conclusion
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/Bion A Shelden/Primary Examiner, Art Unit 3685 2025-12-19