DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This is the first office action on the merits in response to the preliminary amendment filed on 01/04/2024. Claims 1-15 are pending and being examined.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: "1000" (page 25, line 1 of last para.; page 27, line 1 of 2nd para.; and page 29, 5th to last line).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 9-10, 12, and 14 are objected to because of the following informalities:
Claim 1, line 7: “magnetization” is believed to be in error for --a magnetization--
Claim 1, line 11: “the single-use item” is believed to be in error for --the single-use medical item-- (see claim 1, line 1)
Claim 9, line 8: “possibility in the in the drug library” is believed to be in error for --possibility in the drug library--
Claim 10, lines 3-4: “as an identifying feature” is believed to be in error for --as the identifying feature-- (see claim 8, line 8)
Claim 10, lines 8-9: “a correct position” is believed to be in error for --the correct position-- (see claim 10, line 6)
Claim 12, line 2: “a medical device according to claim 9” is believed to be in error for --the medical device according to claim 9--
Claim 14, line 3: “the medical method” is believed to be in error for --the method-- (see claim 14, line 1)
Claim 14, line 7: “a position” is believed to be in error for --the position-- (see claim 8, line 11)
Appropriate correction is required.
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:
“detection system” in claims 8 and 12
“control unit” in claims 8-11 and 13
“storage unit” in claim 9
“position determining module” in claim 11
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
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 9 and 11-13 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.
Regarding claim 9, the limitation “a single-use medical item” in line 13 renders the claim indefinite because it is not known whether this limitation refers to the same “single-use medical item” of claim 8, line 3; to the “further single-use medical item” of claim 9, line 9; or to an additional (i.e., third) single-use medical item that is different from the aforementioned. For examination purposes, the limitation will be treated as referring to the same “single-use medical item” of claim 8, line 3.
Claim 11 recites the limitation "the drug library" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 is also rejected because it depends on claim 9.
Claim 13 recites the limitation "the " in line 7. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
STEP 1:
Regarding claim 15, the claim recites a series of structural elements, including a computer-readable storage medium and a computer. Thus, the claim is directed to a machine, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE:
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of “cause the computer to perform the method of operating the medical device according to claim 14”, which includes:
identifying the identifying feature of the single-use medical item by the detection system and thus identifying the single-use medical item and/or a position of the single-use medical item; and
filtering and/or limiting, based on the basis of the identified single-use medical item, a drug selection and/or a single-use item selection and/or outputting an alarm and/or prohibiting a therapy
set forth a judicial exception. These steps describe concepts performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a mental process, which is an abstract idea.
STEP 2A, PRONG TWO:
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation of the judicial exception. Claim 15 recites the step of “filtering and/or limiting, based on the basis of the identified single-use medical item, a drug selection and/or a single-use item selection and/or outputting an alarm and/or prohibiting a therapy”. The filtering and/or limiting, outputting, and/or prohibiting do not provide an improvement to the technological field, and the method does not effect a particular treatment or effect a particular change based on the filtering and/or limiting, outputting, and/or prohibiting. In addition, the generically recited computer elements (computer-readable storage medium and computer) do not add a meaningful limitation to the abstract idea on a computer because they amount to simply implementing the abstract idea on a computer.
STEP 2B:
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Claim 15 recites the following:
identifying the identifying feature of the single-use medical item by the detection system and thus identifying the single-use medical item and/or a position of the single-use medical item (mental process: evaluation); and
filtering and/or limiting (insignificant extra-solution activity: selecting a particular data source or type of data to be manipulated), based on the basis of the identified single-use medical item, a drug selection and/or a single-use item selection and/or outputting an alarm (insignificant extra-solution activity: data outputting) and/or prohibiting a therapy (insignificant extra-solution activity: insignificant application).
The above steps do not provide significantly more than the judicial exception. The step of “identifying the identifying feature …” is a well-understood, routine, conventional activity. The steps of “filtering/limiting…” and/or “output an alarm” and/or “prohibiting a therapy” are merely insignificant extra-solution activities. Moreover, the additional elements of “a computer-readable storage medium comprising instructions which, when executed by a computer” are well-understood, routine, conventional computer functions as recognized by court decisions listed in MPEP § 2106.05(d).
Furthermore, claim 15 depends upon claim 14, which is a method claim. Claim 14 depends upon claim 10, which is an apparatus claim. Therefore, claim 15 mixes an apparatus claim with a method claim, and the method claim is additionally mixed with an apparatus claim. It is suggested that claim 15 be rewritten in independent form in order to focus the claim to a singular claim type.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claims 1-5, 7-8, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Simpson (US 2009/0204075 A1: IDS reference).
Regarding claim 1, Simpson teaches (Fig. 1) a single-use medical item (12) for use on or in a medical device (14), the single-use medical item (12) comprising at least one integrated marker (38) as an identifying feature (¶ [0037], l. 1), wherein the at least one integrated marker (38) is a predefined portion of the single-use medical item (12) having at least one of:
a color (¶ [0012], ll. 8-11: “The optical signaling component may further be a color…with a respective optical detection device adapted to detect the color”);
magnetization (¶ [0063], ll. 8-11: “Signaling component 116 may include…a magnetic signaling component” – see *Note below);
a geometric shape (¶ [0015], l. 6);
a predefined conductivity (¶ [0013], ll. 5-6); and
an RFID tag (¶ [0046], ll. 4-7: “One method of encryption in the infusion system 10 is to place the encrypted key onto the infusion set 12 as an embedded RFID tag (e.g. signaling component 38) on slide clamp 26” – see also Fig. 3, ref. no. “96”) embedded in the single-use item (12).
*Note: Fig. 5 includes all of the aforementioned elements of Fig. 1, but also allows for the signaling component (38 – Fig. 1; 116 – Fig. 5) to be disposed on any component of infusion set 112 (¶ [0063], ll. 1-2).
Regarding claim 2, Simpson teaches the invention as claimed and as discussed above for claim 1, and Simpson further teaches (Fig. 1) at least one integrated marker comprises at least two markers (38) of a different kind, the at least two markers comprising a first marker (first 38) as a first identifying feature (chosen from ¶ [0002], ll. 8-11, e.g., magnetic) and a second marker (second 38) as a second identifying feature (chosen from ¶ [0002], ll. 8-11, e.g., optical) so as to have a combined or two-stage identification performed by the medical device (14) – (¶ [0002], ll. 8-11: “The signal component or device may be optical (e.g. read a barcode), electrical, RFID, magnetic, chemical, ultrasonic, mechanical or combinations thereof”).
Regarding claim 3, Simpson teaches the invention as claimed and as discussed above for claim 1, and Simpson further teaches (Fig. 1) the at least one integrated marker (38) comprises at least two markers (38) of a different kind (chosen from ¶ [0002], ll. 8-11), the at least two markers comprising a first marker (first 38) as a first identifying feature comprising a radio transponder (¶ [0053], ll. 1-3: “the signaling component may be a radio frequency (RF) signaling component”) and a second marker (second 38) as a second identifying feature comprising the predefined portion having the color (¶ [0012], ll. 8-9: “The optical signaling component may further be a color”. Note that ¶ [0002], ll. 8-11 teaches that the signaling component may be “combinations thereof” of optical and RFID).
Regarding claim 4, Simpson teaches the invention as claimed and as discussed above for claim 1, and Simpson further teaches (Fig. 1) the single-use medical item (12) is an infusion tube (24) comprising, at least at a portion, a color coating or an insertion of color pigments (¶ [0012], ll. 8-9: “The optical signaling component may further be a color”. Note that ¶ [0019], ll. 1-3 teaches that “The signaling component may be disposed on any component of the infusion set, namely, the infusate source, the infusate tube”).
Regarding claim 5, Simpson teaches the invention as claimed and as discussed above for claim 2, and Simpson further teaches (Fig. 1) a single-use medical item set comprising:
at least two single-use medical items according to claim 2 (there are multiple infusion sets 12, each with its own identifier),
the at least two single-use medical items comprising a first single-use medical item (first 12) and a second single-use medical item (second 12),
the first marker (first 38) of the first single-use medical item (first 12) comprising a first configuration and the second marker (second 38) of the second single-use medical item (second 12) comprising a second configuration different from the first configuration (¶ [0037], l. 1: “Signaling component 38 identifies infusion set 12”) so as to differentiate the first single-use medical item (first 12) from the second single-use medical item (second 12) – (since signaling component 38 identifies the particular infusion set, a first infusion set will obviously have a different signaling component 38 than that of a second infusion set).
Regarding claim 7, Simpson teaches the invention as claimed and as discussed above for claim 5, and Simpson further teaches (Fig. 1) the first single-use medical item (first 12) is a first infusion tube (first 24) and the second single-use medical item (second 12) is a second infusion tube (second 24), and
wherein a first end portion of the first infusion tube (first 24) comprises a first radially outer surface of a first color (¶ [0012], ll. 8-9: “The optical signaling component may further be a color”. Note that ¶ [0019], ll. 1-3 teaches that “The signaling component may be disposed on any component of the infusion set, namely, the infusate source, the infusate tube”), and a second end portion of the second infusion tube (second 24) comprises a second radially outer surface of a second color different from the first color (¶ [0012], ll. 8-13: “The optical signaling component may further be a color…with a respective optical detection device adapted to detect the color…and identify the particular infusion set therefrom”. This implies that various colors are used between various infusion sets, and the particular color identifies the particular infusion set).
Regarding claim 8, Simpson teaches (Fig. 1) a medical device (14) comprising:
a receptacle (15) or a connection for a single-use medical item (12) to be inserted in or connected to the medical device (14);
a detection system (16) for detecting at least one integrated marker (38) adapted to the detection system (16) as an identifying feature (see ¶ [0051]) of the single-use medical item (12); and
a control unit (20) adapted to identify the single-use medical item (12) based on the identifying feature (¶ [0041], ll. 7-9) and/or to determine a position of the single-use medical item (12) relative to the detection system (16).
Regarding claim 10, Simpson teaches the invention as claimed and as discussed above for claim 8, and Simpson further teaches (Figs. 1 and 5 – see *Note below) the detection system (16 – Fig. 1; 126 – Fig. 5) comprises a magnetic sensor configured to detect a magnetic field of the single-use medical item (12 – Fig. 1; 112 – Fig. 5) as an identifying feature (¶ [0063], ll. 8-11: “Signaling component 116 may include…a magnetic signaling component”. Therefore, detection system 126 would also include a magnetic sensor), and a color sensor configured to detect a color of a predefined portion of the single-use medical item (12, 112) received or connected (¶ [0012], ll. 8-11: “The optical signaling component may further be a color…with a respective optical detection device adapted to detect the color”), wherein the control unit (20 – Fig. 1; 128 – Fig. 5) is configured, in a first stage, to determine a correct position and hence a correct reception or a correct connection of the single-use medical item (12, 112) based on the magnetic field (¶ [0064], ll. 2-6: “Detection device 126 may be disposed on an exterior surface of infusion device 114. This enables a health care professional or the infusion patient to place signaling component 116 within the detection zone of detection device 126”. Therefore, detection device 126 will detect that medical item 112 has been correctly connected based on signaling component 116, which includes a magnetic signal) and to identify the single-use medical item (12, 112) based on the color in a second stage when, a correct position of the single-use item is detected (per ¶ [0064], ll. 2-6, detection device 126 will detect that medical item 112 has been correctly connected based on signaling component 116, which includes a color signal).
*Note: Fig. 5 includes all of the aforementioned elements of Fig. 1, but also allows for the signaling component (38 – Fig. 1; 116 – Fig. 5) to be disposed on any component of infusion set 112 (¶ [0063], ll. 1-2).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Simpson (US 2009/0204075 A1: IDS reference), in view of Bindra (US 8,308,043: IDS reference).
Regarding claim 6, Simpson teaches the invention as claimed and as discussed above for claim 5, and Simpson further teaches (Fig. 1) the first marker of the first single-use medical item (first 12) is a first magnetization and the first marker of the second single-use medical item(second 12) is a second magnetization (¶ [0063], ll. 8-11: “Signaling component 116 may include…a magnetic signaling component” – see *Note below. Since each infusion set 12, 112 has its own signaling component 38, 116, each infusion set 12, 112 will also have its own magnetization).
*Note: Fig. 5 includes all of the aforementioned elements of Fig. 1, but also allows for the signaling component (38 – Fig. 1; 116 – Fig. 5) to be disposed on any component of infusion set 112 (¶ [0063], ll. 1-2).
However, Simpson does not teach wherein the first magnetization has a first spatial position and a first strength of magnetization, and the second magnetization has a second spatial position and a second strength of magnetization, and
wherein the first spatial position is different from the second spatial position, and/or the first strength of magnetization is different from the second strength of magnetization, so as to differentiate the first single-use medical item from the second single-use medical item.
Bindra teaches (Figs. 2 and 7-9) a single-use medical item set (set of single use loading units (SULU) 16 – Fig. 2) comprising a first single-use medical item (first 16) and a second single-use medical item (second 16),
wherein a first marker of the first single-use medical item (first 16) is a first magnetization and the first marker of the second single-use medical item (second 16) is a second magnetization (col. 6, ll. 9-13: “various SULUs 16 may be provided with the surgical stapling device 10 and each SULU 16 has a configuration of magnets 30 that correspond to features of the particular SULU 16”); and further teaches:
wherein the first magnetization has a first spatial position (various spatial positions of magnets 30 are shown in Figs. 7-9) and a first strength of magnetization (col. 5, ll. 64-66: “Each characteristic to be identified will correspond to a magnet 30 having a different magnetic strength, i.e., gauss power”), and the second magnetization has a second spatial position and a second strength of magnetization, and
wherein the first spatial position is different from the second spatial position (as shown by the various spatial positions in Figs. 7-9), and/or the first strength of magnetization is different from the second strength of magnetization (col. 5, ll. 64-66), so as to differentiate the first single-use medical item (first 16) from the second single-use medical item (second 16) – (col. 5, ll. 27-30: “the sensors 35 may detect particular characteristics of the magnets 30 that correspond with a particular SULU 16, 254 for identification and/or status purposes of the SULU 16, 254”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Simpson such that the first magnetization has a first spatial position and a first strength of magnetization, and the second magnetization has a second spatial position and a second strength of magnetization, and wherein the first spatial position is different from the second spatial position, and/or the first strength of magnetization is different from the second strength of magnetization, so as to differentiate the first single-use medical item from the second single-use medical item, in order to use the particular characteristics (e.g., strength) of the first and second magnetizations to identify each of the first and second single-use medical items, as taught by Bindra (col. 5, ll. 27-30).
Claims 9 and 11-15 is rejected under 35 U.S.C. 103 as being unpatentable over Simpson (US 2009/0204075 A1: IDS reference), in view of Despa (US 2016/0213843 A1).
Regarding claim 9, Simpson teaches the invention as claimed and as discussed above for claim 8, and Simpson further teaches (Fig. 1) a storage unit with a drug library in which data concerning drugs are stored (¶ [0042], ll. 13-15: “System 10 is adapted to identify from one to about 64 or more different predetermined administration protocols”).
However, Simpson does not teach wherein the control unit is adapted to:
filter and/or limit a drug selection possibility in the in the drug library,
filter and/or to limit a selection possibility of a further single-use medical item, and/or
output an alarm and/or prohibit a start of a therapy of the medical device when setting the therapy with a predefined combination of a drug or drug concentration and a single-use medical item.
Despa teaches (Figs. 1A-3) a similar medical device (100 – Figs. 1A-2) comprising a control unit (160 – Fig. 3) adapted to identify a single-use medical item (tubing that contains the liquid to be pumped – see ¶ [0038], ll. 5-7) based on an identifying feature (¶ [0065], ll. 4-5: “The identification sensors 185 can detect the identity of the RF tag or bar code on the infusate”) and a storage unit with a drug library in which data concerning drugs are stored (¶ [0005], l. 8: “Existing devices can store and retrieve drug libraries”); and further teaches:
wherein the control unit (160) is adapted to:
filter and/or limit a drug selection possibility in a drug library (¶ [0005], ll. 8-11: “…and have safeguards capable of preventing gross programming errors if ineffective or life-threatening infusion parameters are attempted for a particular drug” – see also ¶ [0065], ll. 9-11),
filter and/or limit a selection possibility of the single-use medical item (¶ [0032], ll. 1-6: “the infusion device can be configured to prevent infusion, terminate infusion, or prevent further infusion based on the occurrence of one or more predetermined events, such as, for example, determination that data from one or more environmental sensors is outside of a defined range”), and/or (see *Note below)
output an alarm (¶ [0065], ll. 11-14: “In response to confirming or not confirming the identity of an infusate, the computing module 160 can also be configured to transmit a message to the touch display 104”) and/or (see *Note below) prohibit a start of a therapy of the medical device (100) when setting the therapy with a predefined combination of a drug or drug concentration and a single-use medical item – (¶ [0065], ll. 9-11: “If the identity of the infusate is not confirmed, the computing module 160 can be configured to prevent infusion from occurring”).
*Note: the recitation “and/or” indicates that the subsequent limitation is an alternative. Since there are four limitations linked by “and/or”, only one out of the four limitations is required to be taught by the prior art for the claim to be anticipated or obvious.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Simpson by adapting the control unit to: filter and/or limit a drug selection possibility in the in the drug library, filter and/or to limit a selection possibility of a further single-use medical item, and/or output an alarm and/or prohibit a start of a therapy of the medical device when setting the therapy with a predefined combination of a drug or drug concentration and a single-use medical item, in order to provide safeguards capable of preventing gross programming errors if ineffective or life-threatening infusion parameters are attempted for a particular drug, and to notify a user that it may not be safe to administer infusion and may prevent infusion from occurring, as taught by Despa (¶ [0005], ll. 8-11 and Abstract).
Regarding claim 11, Simpson teaches the invention as claimed and as discussed above for claim 8, except for a position determining module with a stored assignment of communications network to position determination,
wherein the control unit is configured to, based on a determined position of the medical device:
filter and/or limit a drug selection possibility in the drug library, and/or
filter and/or limit a selection possibility of the single-use medical item.
Despa teaches (Figs. 1A-3) a similar medical device (100 – Figs. 1A-2) comprising a control unit (160 – Fig. 3) adapted to identify a single-use medical item (tubing that contains the liquid to be pumped – see ¶ [0038], ll. 5-7) based on an identifying feature (¶ [0065], ll. 4-5: “The identification sensors 185 can detect the identity of the RF tag or bar code on the infusate”); and further teaches:
a position determining module (location sensors 195 – Fig. 3 and environmental sensors – ¶ [0032], l. 5) with a stored assignment of communications network to position determination (¶ [0081], ll. 1-2),
wherein the control unit (160) is configured to, based on a determined position of the medical device:
filter and/or limit a drug selection possibility in a drug library (¶ [0005], l. 8), and/or
filter and/or limit a selection possibility of the single-use medical item (¶ [0032], ll. 1-6: “the infusion device can be configured to prevent infusion, terminate infusion, or prevent further infusion based on the occurrence of one or more predetermined events, such as, for example, determination that data from one or more environmental sensors is outside of a defined range”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Simpson by including a position determining module with a stored assignment of communications network to position determination, and configuring the control unit to, based on a determined position of the medical device: filter and/or limit a drug selection possibility in the drug library, and/or filter and/or limit a selection possibility of the single-use medical item, in order to prevent infusion, terminate infusion, or prevent further infusion based on data from the position determine module that is outside of a defined range, and additionally to use the data to allow a user to contact the nearest emergency services provider, as taught by Despa (¶ [0032], ll. 1-6 and ¶ [0034], ll. 20-23).
Regarding claim 12, Simpson, in view of Despa, teaches the invention as claimed and as discussed above for claim 9, and Simpson further teaches (Fig. 1) a medical system (10), comprising:
a medical device (14) according to claim 9; and
a single-use medical item set (there are multiple infusion sets 12, each with its own identifier) comprising;
a first single-use medical item (a first infusion set 12) and a second single-use medical item (a second infusion set 12),
the first single-use medical item (first 12) comprising a first integrated marker of a first configuration (first 38), and the second single-use medical item (second 12) comprising a second integrated marker of a second configuration (second 38) different from the first configuration (¶ [0037], l. 1: “Signaling component 38 identifies infusion set 12”),
the first integrated marker (first 38) and the second integrated marker (second 38) each being a predefined identifying feature that is detectable by the detection system (16) of the medical device (14) – (¶ [0044], ll. 1-3: “Upon detection of signaling component 38, detection device 16 generates a signal that is based on the infusion set identified by the signaling component”),
the second configuration being different from the first configuration so as to differentiate the first single-use medical item (first 12) from the second single-use medical item (second 12) – (since signaling component 38 identifies the particular infusion set, a first infusion set will obviously have a different signaling component 38 than that of a second infusion set).
Regarding claim 13, Simpson, in view of Despa, teaches the invention as claimed and as discussed above for claim 12, and Simpson further teaches (Figs. 1 and 3) wherein:
the first integrated marker (first 38) and the second integrated marker (second 38) each comprise an RFID tag (¶ [0046], ll. 4-7: “One method of encryption in the infusion system 10 is to place the encrypted key onto the infusion set 12 as an embedded RFID tag (e.g. signaling component 38) on slide clamp 26” – see also Fig. 3, ref. no. “96”),
the medical device (14) comprises an RFID reader (detection device 16 is designed to read the embedded RFID tag; also shown in Fig. 3 as RF interrogator 102) digitally providing read-out data of each RFID tag (96) to the control unit (20), and
the control unit (20) is configured to limit, based on the basis of a patient library with data stored for patients, the drug selection possibility in the drug library (¶ [0042], ll. 13-15) and to display the drug selection possibility via a display (21) to a user (¶ [0045], ll. 5-8).
Regarding claim 14, Simpson teaches the invention as claimed and as discussed above for claim 10, and Simpson further teaches (Fig. 1) a method of operating the medical device (14) according to claim 10, the medical method comprising the steps of:
identifying the identifying feature (38) of the single-use medical item (12) by the detection system (16) and thus identifying the single-use medical item (12) – (¶ [0043], ll. 4-5: “Detection device 16 detects or otherwise determines the infusion set identified by signaling component 38”) and/or a position of the single-use medical item (12).
However, Simpson does not teach filtering and/or limiting, based on the basis of the identified single-use medical item, a drug selection and/or a single-use item selection and/or outputting an alarm and/or prohibiting a therapy.
Despa teaches (Figs. 1A-3) a similar medical device (100 – Figs. 1A-2) comprising a control unit (160 – Fig. 3) adapted to identify a single-use medical item (tubing that contains the liquid to be pumped – see ¶ [0038], ll. 5-7) based on an identifying feature (¶ [0065], ll. 4-5: “The identification sensors 185 can detect the identity of the RF tag or bar code on the infusate”) and to perform the functions of:
filtering and/or limiting, based on the basis of the identified single-use medical item, a drug selection and/or (see *Note below) a single-use item selection (¶ [0032], ll. 1-6: “the infusion device can be configured to prevent infusion, terminate infusion, or prevent further infusion based on the occurrence of one or more predetermined events, such as, for example, determination that data from one or more environmental sensors is outside of a defined range”) and/or (see *Note below) outputting an alarm (¶ [0065], ll. 11-14: “In response to confirming or not confirming the identity of an infusate, the computing module 160 can also be configured to transmit a message to the touch display 104”) and/or (see *Note below) prohibiting a therapy (¶ [0065], ll. 9-11: “If the identity of the infusate is not confirmed, the computing module 160 can be configured to prevent infusion from occurring”).
*Note: the recitation “and/or” indicates that the subsequent element/limitation is an alternative. For the first “and/or”, only one out of the three “based on” elements is required to be taught by the prior art. For the second and third “and/or”, only one out of the three functional limitations is required to be taught by the prior art.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Simpson by adapting the control unit to perform the functions of: filtering and/or limiting, based on the basis of the identified single-use medical item, a drug selection and/or a single-use item selection and/or outputting an alarm and/or prohibiting a therapy, in order to provide safeguards capable of preventing gross programming errors if ineffective or life-threatening infusion parameters are attempted for a particular drug, and to notify a user that it may not be safe to administer infusion and may prevent infusion from occurring, as taught by Despa (¶ [0005], ll. 8-11 and Abstract).
Regarding claim 15, Simpson, in view of Despa, teaches the invention as claimed and as discussed above for claim 14, and Simpson further teaches (Fig. 1) a computer-readable storage medium comprising instructions (¶ [0041], ll. 7-11: “controller 20 is programmed to recognize the predetermined information represented by the alpha-numeric characters. Controller 20 then configures infusion device 14 according to these predetermined parameters.” Since controller 20 is programmed with these instructions, these instructions must be stored somewhere) which, when executed by a computer, cause the computer to perform the method of operating the medical devices (14) according to claim 14 (¶ [0045], ll. 1-2: “Controller 20 includes a processor to process the infusion set information contained in the signal”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure: see attached form PTO-892 “Notice of References Cited”.
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/HENRY NG/Examiner, Art Unit 3741
/DEVON C KRAMER/Supervisory Patent Examiner, Art Unit 3741
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