DETAILED ACTION
Status of Claims
The present application is being examined under the pre-AIA first to invent provisions.
This action is in reply to a response filed 18 June 2026, on an application filed 27 December 2021, which claims domestic priority to provisional applications filed as far back as 12 December 2011.
On 4 April 2024, the Applicant filed and the Office accepted a terminal disclaimer for this application over U.S. Patent No. 11,210,611.
Claims 1-12 have been amended.
Claims 13-20 have been added by amendment.
Claims 1-20 are currently pending and have been examined.
EXAMINATION NOTE
The Office notes that the claims contain multiple terms that are not explicitly defined in the claims or the specification as filed. Therefore, the Office is providing the following definitions under a broadest reasonable interpretation analysis.
The online Wiktionary dictionary defines:
web service as a “software system designed to support interoperable machine to machine interaction over a network.”
web server as “software that delivers web pages and other documents to browsers using the HTTP protocol.”
The online Wikipedia describes a gateway as “a link between two computer programs or systems such as Internet Forums. A gateway acts as a portal between two programs allowing them to share information by communicating between protocols on a computer or between dissimilar computers.”
The online Computer Desktop Encyclopedia describes a web client as “[t]he client, or user, side of the Web. It typically refers to the Web browser in the user's machine.”
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.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
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.
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 recit
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 es 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:
“must be within a predetermined distance relative to each other as indicated by the respective ranging module” and “communications module configured for authenticating” 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 limitation “must be within a predetermined distance relative to each other as indicated by the respective ranging module” and “communications module configured for authenticating” has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder module coupled with functional language “must be within a predetermined distance relative to each other as indicated” and “configured for authenticating” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim(s) 1 and 13 has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation: paragraph 579 indicates that the modules can be composed of hardware comprised of an expansion cartridge for inserting into an expansion slot.
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Claim Objections
Claim 1 is objected to because of the following informalities: the said hub limitation is not followed by punctuation as the existing punctuation has been stricken.
Claim 15 is objected to because of the following informalities: the type of the term table for the apparent term tablet.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claims 1 and 12 recites limitations directed to said medical device is enabled for the treating and enabling executing the updated prescription. As written, it is unclear whether the material following the terms enabled/enabling are required by the claim because the terms enabled/enabling are not a positive recitation. Accordingly, the metes and bounds of the claims are unclear.
To the extent that other claims rely on claims that are rejected under 35 USC 112 and fail to correct the deficiencies of the claims they rely on, those other claims are rejected for the same reasons as the claims they rely on. Appropriate correction is required.
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 1-20 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.
Step 1
Claims 1-20 are within the four statutory categories. Claims 12, 19 and 20 are drawn to a method of providing patient care, which is within the four statutory categories (i.e. process). Claims 1-11 and 13-18 are drawn to a system for electronic patient care, which is within the four statutory categories (i.e. machine).
Prong 1 of Step 2A
Claim 12 recites: Method of providing patient care comprising:
authenticating a medical device configured for treating a patient;
determining a safety of an updated prescription;
communicating the safety to an electronic medical records (EMR) application and a hub;
communicating the updated prescription to the medical device;
enabling executing the updated prescription after the prescription is confirmed at the medical device; and
monitoring a distance between the hub and the medical device;
wherein said enabling depends on the hub and the medical device existing within a predetermined distance relative to each other.
The underlined limitations as shown above, given the broadest reasonable interpretation, cover the abstract idea of a mental process and/or a certain method of organizing human activity because they recite managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions – in this case the step of determining the safety of a prescription, sending it to medical records, and then executing the prescription treatment on a patient after all necessary devices are located nearby, operations performed by a treating caregiver), e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea(s) are deemed “additional elements,” and will be discussed in further detail below.
Dependent claims 19 and 20 include other limitations, for example claims 19 and 20 display data, but these only serve to further narrow the abstract idea, and a claim may not preempt abstract ideas, even if the judicial exception is narrow, e.g. see MPEP 2106.04. Additionally, any limitations in dependent claims 19 and 20 not addressed above are deemed additional elements to the abstract idea, and will be further addressed below. Hence dependent claims 19 and 20 are nonetheless directed towards fundamentally the same abstract idea as independent claim 12.
Prong 2 of Step 2A
Claims 12, 19 and 20 are not integrated into a practical application because the additional elements (i.e. any limitations that are not identified as part of the abstract idea) amount to no more than limitations which:
generally link the abstract idea to a particular technological environment or field of use – for example, the recitation of the hub, the medical device and the application, which amounts to limiting the abstract idea to the field of healthcare, see MPEP 2106.05(h); and/or
adding insignificant extrasolution activity to the abstract idea, for example mere data gathering, selecting a particular data source or type of data to be manipulated, and/or insignificant application (e.g. see MPEP 2106.05(g)).
Additionally, dependent claims 19 and 20 include other limitations, but these limitations also amount to no more than generally linking the abstract idea to a particular technological environment or field of use (e.g. the types of data disclosed in dependent claims 19 and 20), and/or do not include any additional elements beyond those already recited in independent claim 12, and hence also do not integrate the aforementioned abstract idea into a practical application.
Step 2B
Claims 1-20 do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because the additional elements (i.e. the non-underlined limitations above – in this case, the medical device, the application and the hub), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, generally link the abstract idea to a particular technological environment or field of use, and/or add insignificant extra-solution activity to the abstract idea, wherein the insignificant extra-solution activity comprises limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification expressly disclosing that the additional elements are well-understood, routine, and conventional in nature:
Paragraph 650 of the Specification discloses that the additional elements (i.e. the application) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions (i.e. receive and process data) that are well-understood, routine, and conventional activities previously known to the pertinent industry (i.e. healthcare);
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added));
ii. Performing repetitive calculations, Flook, 437 U.S. at 594, 198 USPQ2d at 199 (recomputing or readjusting alarm limit values); Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims.");
iii. Electronic recordkeeping, Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 225, 110 USPQ2d 1984 (2014) (creating and maintaining "shadow accounts"); Ultramercial, 772 F.3d at 716, 112 USPQ2d at 1755 (updating an activity log); and
iv. Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Dependent claims 19 and 20 include other limitations, but none of these limitations are deemed significantly more than the abstract idea because, as stated above, the aforementioned dependent claims do not recite any additional elements not already recited in independent claims 12, and/or the additional elements recited in the aforementioned dependent claims similarly amount to generally linking the abstract idea to a particular technological environment or field of use (e.g. the types of data disclosed in dependent claims 19 and 20), and hence do not amount to “significantly more” than the abstract idea.
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claims 12, 19 and 20 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1, 4-10, 12, 14, 15 and 17-20 are rejected under 35 U.S.C. 103(a) as being obvious over Holland et al. (U.S. PG-Pub 2005/0144043 A1), hereinafter Holland, in view of Baldus et al. (U.S. PG-Pub 2007/0271115 A1), hereinafter Baldus, or, in the alternative, further in view of Deberadine (U.S. PG-Pub 2013/0261561 A1), hereinafter Deberadine.
As per claims 1, 12 and 15, Holland discloses a method and system for electronic patient care (Holland, Figs. 1A and 5.), the system comprising:
a hub configured for executing a medical device application (Holland discloses Medication Management Unit [MMU] #12, see paragraphs 69-71.);
a medical device configured for: treating a patient; and communicating with said hub (Holland discloses medical device #14, which is connected to Hub. Hub is operative to control multiple pumps, see paragraphs 27, 28, 69, 74-76. Holland discloses the use of Bluetooth communications, which are known to be paired, see paragraphs 6, 56, 69, 74, 75, 100, 109, 120 and 144.); and
a monitoring client configured for communicating with said hub (Holland discloses PDA #32 containing a user interface, see paragraphs 84 and 154.); wherein:
when a prescription is updated within an electronic medical records (EMR) application via said monitoring client, the EMR application queries an EMR database to determine a safety of the updated prescription for the patient (Holland, Fig. 5 #S 136-140 and paragraph 84: user enters patient ID into PDA ##32 which forwards that to the HIS #18 that communicates with MAR #22, see paragraph 65; HIS responds with a task list for the patient in order to provide a 5-rights check to determine the safety of the prescription for the patient. Accordingly, the EMR application accessed by HIS #18 is utilized by PDA #32 in order to determine the safety of the prescription for the patient. MMU performs the safety check in an alternative embodiment, see paragraph 84. In another embodiment at paragraph 103 updated information is provided to the system, and HIS #18 [that communicates with MAR #22, see paragraph 65] determines whether the updated order would be safe by. In yet another embodiment, system uses HIS/MMU to access patient photograph information to determine the five-rights check, see paragraph 129. See also the five-rights check used by accessing HIS #18 of paragraph 145.);
said hub is configured for communicating the updated prescription to said medical device (Prescription sent to pump 14 with patient-specific rule set, see Holland paragraph 89 and Fig. 5A #182.);
said medical device is enabled for the treating after the updated prescription is confirmed at said medical device (See Holland, Fig. 5A #198.);
said medical device is configured for communicating a parameter to said hub (Delivery Events are communicated from the pump to the MMU [hub] to the PDS [tablet], see Fig. 5A #200-204 and paragraph 94.);
said hub is configured for communicating the parameter to said monitoring client (Delivery Events are communicated from the pump to the MMU [hub] to the PDS [tablet], see Fig. 5A #200-204 and paragraph 94.);
said hub, said monitoring client, and said medical device each comprise a functional module (Fig. 5A.);
devices must be within a working distance relative to each other … (System does not operate without all parts, see Holland Fig. 5A.);
said hub, said monitoring client and said medical device must be all available prior to configuration and treatment of the patient (System does not operate without all parts, see Holland Fig. 5A.); and
15. said tablet is configured for generating an alert if one or more of the devices (PDA/Tablet provides alert, see paragraph 108.)
Holland fails to explicitly disclose:
a ranging module;
devices must be within a predetermined distance relative to each other as indicated by the respective ranging module prior to operation; and
15. indicating if the devices are not within a predetermined distance relative to each other.
Baldus discloses wherein:
three devices each include a ranging module (Baldus, discloses a ranging module system for inclusion with at least three devices, such as patient sensor system “CCC”, hospital staff and patient monitors, see paragraphs 37, 40, 41, 61 and 62.) ; and
devices must be within a predetermined distance relative to each other as indicated by the respective ranging module prior to operate (Baldus discloses a system wherein the monitor display is turned off when rules are not met, such as patient CCC, patient monitor and hospital staff being within a detectable vicinity of the location device 19, see paragraphs 37, 40, 41, 61 and 63.), and
indicating if the devices are not within a predetermined distance relative to each other r (Baldus discloses a system wherein the monitor display is turned off when rules are not met, such as patient CCC, patient monitor and hospital staff being within a detectable vicinity of the location device 19, see paragraphs 37, 40, 41, 61 and 63. Herein a blank screen would comprise an indication or alert that the devices do not meet the required rules.),
in order to provide “as a function of the determined location of the medical device, to provide automatic configuration or adaptation of configuration to the new situation of the medical device” (Baldus, paragraph 8.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare data processing at the time of the invention/filing to modify the medication management system of Holland to include three devices containing a ranging module that must be determined to be within a particular distance, as taught by Baldus, in order to provide a medication management system wherein “as a function of the determined location of the medical device, to provide automatic configuration or adaptation of configuration to the new situation of the medical device” (Baldus, paragraph 8.). Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
In the interest of expediting prosecution, the Office will provide a secondary reference disclosing a ranging module wherein devices must be within a predetermined distance relative to each other as indicated by the respective ranging module prior to operation and indicating if the devices are not within a predetermined distance relative to each other (Deberadine uses a ranging module to inhibit operations, which would comprise an indication/alert, when devices are not within a predetermined minimum distance from each other, see paragraphs 12, 38, 39 and paragraph 15.) in order to prevent a situation wherein a determined treatment will not be functionally administered correctly due to device locations.
Therefore, it would have been obvious to one of ordinary skill in the art of medical claim analysis and patient treatment at the time of the invention/filing to modify the medication management system of Holland to include a ranging module wherein devices must be within a predetermined distance relative to each other as indicated by the respective ranging module prior to operation and indicating if the devices are not within a predetermined distance relative to each other, as taught by Deberadine, in order to provide the medication management system that can prevent a situation wherein a determined treatment will not be functionally administered correctly due to device locations. Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Holland, Baldus and Deberadine are all directed to the processing of healthcare data to provide care to a patient.
As per claims 4-10, 14 and 17-20 Holland/Baldus, or, in the alternative, Holland/Deberadine, disclose claims 1 and 12, discussed above. Holland also discloses:
4. wherein said medical device of the plurality of medical devices is an infusion pump (Holland, hub is operative to control multiple pumps, see paragraphs 27, 28, 69, 74-76.);
5. wherein said hub is configured to for controlling access from the medical device application to at least one hardware resource (Holland, MMU hub is operative to control multiple pumps, see paragraphs 27, 28, 69, 74-76.);
6. said hub is configured for prioritizing access to an alarm resource.
(Holland discloses the MMU accessing and controlling an audible alarm, see paragraphs 23-24.);
7. wherein the alarm resource is a speaker (Holland discloses the MMU accessing and controlling an audible alarm, see paragraphs 23-24. It is the Office’s position that given the system of Holland which provides an audible alarm, it would obvious to one of ordinary skill in the art to provide the audible alarm using a speaker.);
8. wherein the medical device application is configured for routing at least two alarm conditions to said monitoring client (Holland, Fig. 5A #178.);
9. wherein said monitoring client is configured for communicating the parameter to a server (All delivery events are communicated to hospital information system, see Fig. 5A #208 of Holland.);
10. wherein said medical device is configured for broadcasting the parameter (As shown above, Holland discloses a pump transmitting data. The online Wiktionary dictionary defines broadcast as “Communicated, signaled, or transmitted through radio waves or electronic means.” Accordingly, any transmission of data through electronic means would comprise a broadcast, as shown in Holland.);
17. wherein said monitoring client comprises a tablet (Holland discloses PDA #32 containing a user interface, see paragraphs 84 and 154.);
14,20. wherein said monitoring client is configured for displaying the parameter on said monitoring client (Delivery Events are communicated from the pump to the MMU [hub] to the PDS [tablet], see Fig. 5A #200-204 and paragraph 94.); and
18,19. wherein said monitoring client is configured for causing a user interface of said medical device to display a confirmation request of the updated prescription (Prescription presented on pump interface at Fig. 5A #188 to be confirmed by provider, see Holland paragraph 91.).
Claims 2, 3 and 16 are rejected under 35 U.S.C. 103(a) as being obvious over Holland/Baldus, or, in the alternative, Holland/Deberadine, further in view of Blomquist (U.S. Patent 8,954,336 B2), hereinafter Blomquist.
As per claims 2, 3 and 16, Holland/Baldus, or, in the alternative, Holland/Deberadine, discloses claims 1 and 8, discussed above.
Holland/Baldus fails to explicitly disclose:
2. a gateway configured for providing a web server of a web service and said medical device is a client of the web service;
3. wherein the web service is a transaction-based web service; and
16. wherein the routing comprises an Extensible Markup Language ("XML").
Blomquist teaches that it was old and well known in the art of patient monitoring and treatment application at the time of the invention/filing to include:
2. a gateway configured for providing a web server of a web service and said medical device is a client of the web service. (Blomquist, C3L61-C4L10, where the pump server serves a web service (web browser interface) to the medical device and Fig. 7. Note the definitions of gateway, web service, web client and web server indicated above. The pump server #100 provides a gateway to communicate with the medical device via a web service, the pump interface driver. See also C3L61-C4L10, where the pump server serves a web service (web browser interface) to the medical device and Fig. 7.);
3. wherein the web service is a transaction-based web service (Blomquist, C3L61-C4L10, where the pump server serves a web service (web browser interface) to the medical device and Fig. 7. This is clearly the transmission and processing of an item of data. Note the definitions of gateway, web service, web client and web server indicated above.); and
16. wherein the routing comprises an Extensible Markup Language ("XML") (Blomquist C6L23-26.);
in order to “permit a remote device to communicate with a medical device … without the use of a … server and without the need for a special program or other interface loaded on the remote device” (Blomquist, C2L19-23).
Therefore, it would have been obvious to one of ordinary skill in the art of medical claim analysis and patient treatment at the time of the invention/filing to modify the medication management system of Holland/Baldus to include a gateway, which is a web server of a web service and the medical device is a client of the web service; and wherein the web service is a transaction-based web service; and wherein the medical device is an infusion pump, in order to provide the medication management system that can “permit a remote device to communicate with a medical device … without the use of a … server and without the need for a special program or other interface loaded on the remote device” (Blomquist, C2L19-23.). Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Both Holland and Blomquist are directed to the processing of healthcare data to provide care to a patient.
Claims 11 and 13 are rejected under 35 U.S.C. 103(a) as being obvious over Holland/Baldus, further in view of Golden (U.S. PG-Pub 2010/0292556 A1), hereinafter Golden.
As per claims 11 and 13, Holland/Baldus, or, in the alternative, Holland/Deberadine, disclose claim 1, discussed above. Holland further discloses:
11. wherein said hub is configured for communicating …: the updated prescription to said medical device; and the parameter to said monitoring client (Prescription sent to pump 14 with patient-specific rule set, see Holland paragraph 89 and Fig. 5A #182. Delivery Events are communicated from the pump to the MMU [hub] to the PDS [tablet/monitoring client], see Fig. 5A #200-204 and paragraph 94.); and
13. a communications module configured for authenticating prior to permitting communications among: said hub … said monitoring client (Holland discloses PDA #32 containing a user interface, see paragraphs 84 and 154. Holland discloses the use of Bluetooth communications, which are known to be paired, see paragraphs 6, 56, 69, 74, 75, 100, 109, 120 and 144. User must be authorized/authenticated by presentation of a badge or similar article, see paragraph 143; only an authorized/authenticated user can communicate with the hub using the tablet, therefore the communications are authorized and authenticated.
Holland/Baldus, or, in the alternative, Holland/Deberadine, fails to explicitly disclose device authentication, nor paired communications between other devices.
Golden, however, teaches that it was old and well known in the art of patient monitoring and treatment application at the time of the invention/filing to provide device to device authentication (See paragraphs 109: “may also be configured to authorize and grant/deny access to a secure environment operating on a medical device. This feature prohibits unauthorized devices and/or medical applications from communicating with the medical device”), and paired communications between devices (Golden, disclose the use of a secure communication environment, see paragraph 109. The online dictionary Wiktionary defines pairing as “to link two electronic devices wirelessly together, especially through a protocol such as Bluetooth.”), in order to provide “methods and systems for managing, controlling and monitoring medical devices via a software application functioning in a secure environment” (Golden, paragraph 2).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare data processing at the time of the invention/filing to modify the medication management system of Holland/Baldus, or, in the alternative, Holland/Deberadine, to include use of a multiprocessor device that enables device to device authentication and pairing, as taught by Golden, in order to result in a medication management system that provides “methods and systems for managing, controlling and monitoring medical devices via a software application functioning in a secure environment” (Golden, paragraph 2). Moreover, merely adding a well-known element into a well-known system, to produce a predictable result to one of ordinary skill in the art, does not render the invention patentably distinct over such combination (see MPEP 2141).
Holland and Golden are both directed to the processing of healthcare data to provide care to a patient.
Response to Arguments
Applicant’s arguments filed 18 June 2026 concerning the rejection of all claims under 35 U.S.C. 1112 have been fully considered and they are persuasive in view of the amendments to the claims. Accordingly, these rejections have been withdrawn.
Applicant’s arguments filed 18 June 2026 concerning the rejection of all claims under 35 U.S.C. 103(a) have been fully considered but they are not persuasive.
With regard to the rejection of the claims under 35 USC 103, Applicant argues on pages 6-7 that the citation of the ‘115 pub (Baldus) does not match the limitations directed to using a ranging module to determine if multiple elements are within a particular range as the cited elements of Baldus are not medical devices and are not directed to inhibiting treatment by a pump.
The Office respectfully disagrees. Baldus is not used to disclose the contested medical devices, nor treatment, Holland is. Baldus is used to show a ranging module and inhibiting operations when the elements are not within range, while Holland discloses the remaining information.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Here the combination of the cited references disclose the contested limitation.
Alternatively, Deberadine discloses the contested limitations, as shown above.
Accordingly, the rejection is upheld.
In conclusion, all of the limitations which Applicant disputes as missing in the applied references, including the features newly added by amendment, have been fully addressed by the Office as either being fully disclosed or obvious in view of the collective teachings of Holland, Baldus, Deberadine, Golden and Blomquist, based on the logic and sound scientific reasoning of one ordinarily skilled in the art at the time of the invention, as detailed in the remarks and explanations given in the preceding sections of the present Office Action and in the prior Office Actions (24 March 2026, 5 September 2025, 20 May 2025, 4 March 2025, 19 September 2024, 14 March 2024 and 30 August 2023), and incorporated herein.
Conclusion
Unused but cited relevant prior art includes:
Baker et al. (U.S. PG-Pub 2012/0003933 A1) discloses medical devices with proximity detection.
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 of a general nature or relating to the status of this application or concerning this communication or earlier communications from the Examiner should be directed to Mark Holcomb, whose telephone number is 571.270.1382. The Examiner can normally be reached on Monday-Friday (8-5). If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Kambiz Abdi, can be reached at 571.272.6702.
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/MARK HOLCOMB/
Primary Examiner, Art Unit 3685
27 August 2026
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