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 .
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.
Election/Restrictions
Applicant's election with traverse of Species B in the reply filed on 16 June 2026 is acknowledged. The traversal is on the ground(s) that:
1. the claims do not recite limitations drawn to the separate species
2. when the claims are generic, restriction can only be required if the claims are not allowable
3. the office action has not established that the alleged species are mutually exclusive or materially different (see [0131, 123, 126, 151, 153, 155]).
4. there is no serious search burden because the claims are generic to the species
This is not found persuasive because:
1. the restriction is based on disclosed species, not claimed species; the form paragraph 8.02 used in the restriction requirement explicitly provides for requiring an election of species where no species claim is present
2. the claims are not allowable over prior art as discussed below (such determination could not be made before the search was conducted)
3. the alleged species have mutually exclusive features and are materially different as evidenced by their different depictions in Figures 3 and 4 and as outlined in the previous office action; although Applicant points to various paragraphs in the Specification, the majority of these paragraphs mention the two method species in the alternative; the only exception being paragraphs that state “and/or” in reference to updating by flow rate or by time period; however this is not sufficient to demonstrate the two methods are part of a single method or invention; for example there is no indication of how to implement both updates at once
4. although the claims are currently generic, the disclosed species may still be restricted for future reference as Applicant proceeds with claim amendments.
The requirement is still deemed proper and is therefore made FINAL.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement filed 21 June 2025 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file.
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 1-17 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 pre-AIA the applicant regards as the invention.
Regarding Claim 1, the recitation(s) “the intake information” is unclear whether this is a new intake information or the same as the total intake previously recited.
Regarding claim 2:
the recitation “the first of second liquid” does not appear to be idiomatic English and is unclear what is being referred to.
“a liquid type” is unclear whether it is related to any of the previously recited liquids
“its ingredient information” is unclear whether it is the same as, or different from, the previously recited ingredient information
“determining the parameter information of each first liquid based on the received parameter information” is unclear whether this parameter information is the same as claim 1. It is also unclear whether this limitation requires the liquid of the first clause to be one of the first liquids or whether this clause is conditional and only applies when the liquid of the first clause is categorized as a first liquid.
Regarding claims 4 and 13, it is unclear whether the “second fluid” is the same as, or different from, the second liquid previously recited.
Regarding claims 5 and 14, “the infusion pump” is unclear because multiple pumps are previously recited and it is unclear which is being referred to. Also, it is unclear whether there is antecedent basis for “the infused amount”.
Regarding claims 6 and 15, “the first liquid or the second liquid” is unclear whether it refers to each first liquid and each second liquid as previously recited, or whether the adjustments to the parameter information of each first liquid and each second liquid should be according to the received updated information of only one first liquid or one second liquid.
Regarding claims 7 and 16, “the ingredient information of the first liquid” is unclear whether it is requiring the ingredient information of claim 2 to be for the first liquid, or whether it is conditional upon the liquid in claim 2 being a first liquid, or whether it is a new limitation on ingredient information. There is also a typo of “first liquid first liquid”.
Regarding claims 8 and 17, “the ingredient information of the second liquid” is unclear whether it is requiring the ingredient information of claim 2 to be for the second liquid, or whether it is conditional upon the liquid in claim 2 being a second liquid, or whether it is a new limitation on ingredient information.
Regarding claim 9, it is unclear whether the recitations of “a patient” and ”a user” are necessarily different or may be the same. The recitation “with desired proportion” is unclear whether this is a new desired portion or whether there is antecedent basis for the desired proportion. Grammatical correction required.
Regarding claim 10, the recitation of “a liquid” is unclear whether it refers to one of the previous liquids. Additionally, the recitation(s) “the intake information” is unclear whether this is a new intake information or the same as the total intake previously recited.
Regarding claim 11:
“a first liquid or a second liquid” is unclear whether it is related to any of the previously recited liquids
“its corresponding parameter information” is unclear whether it is the same as, or different from, the previously recited parameter information or whether it refers to the parameter information of an ingredient
“determining the parameter information of each first liquid based on the received parameter information” is unclear whether this parameter information is the same as claim 1. It is also unclear whether this limitation requires the liquid of the first clause to be one of the first liquids or whether this clause is conditional and only applies when the liquid of the first clause is categorized as a first liquid.
Regarding claim 12, “the input device” lacks antecedent basis in the claims.
Regarding claim 13, it is unclear whether the “second fluid” is the same as, or different from, the second liquid previously recited.
Dependent Claims 2-9 and 11-17 are also rejected for relying on at least one rejected claim above.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3-4, 6, 9-10, 12-13, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peterfreund 10758672.
Regarding Claim 1, Peterfreund teaches a liquid infusion control method (incl. Fig 3A) applied to a liquid infusion system (Fig 1), wherein the liquid infusion system comprises a control device (110), an input device (115) and at least two infusion pumps (105a-c), the method comprising:
determining infusion attribute information (at 320; col.16 ll.1-18), wherein the infusion attribute information includes a total intake of at least one first liquid and at least one second liquid for a predetermined time period (e.g. a target amount of drug to be delivered to the target, a carrier flow rate Q.sub.c, a drug flow rate Q.sub.d, a total flow rate Q.sub.T, a drug delivery rate dd, a target drug delivery rate dd.sub.target, a steady state rate ss, maximum allowable carrier flow Q.sub.cmax, a target steady state carrier flow Q.sub.css) and parameter information of each first liquid (first liquid may be either carrier fluid or drug; e.g. fa target amount of drug to be delivered to the target, a time of drug delivery, a carrier flow rate Q.sub.c, a drug flow rate Q.sub.d, a drug delivery rate dd, a target drug delivery rate dd.sub.target, a steady state rate ss, maximum allowable carrier flow Q.sub.cmax, a target steady state carrier flow Q.sub.css, a stock drug concentration c.sub.d);
determining parameter information of each second liquid based on the infusion attribute information (the second liquid is either a carrier fluid or a drug that is not being interpreted as the first liquid; determination based on the infusion attribute information may include merely selecting, viewing, or using any of the attribute information data points that are related to the second fluid; or the parameter information of each second liquid may be any other relevant parameter that is calculated from other values, per col.16 ll.11-13, 24-26 “Some of these parameters can be calculated from other parameters” and “the initial flow parameters are determined as a combination of received and calculated values”),
wherein the parameter information of each second liquid includes at least two of the intake information, flow rate information and time information (e.g. a target amount of drug to be delivered to the target, a time of drug delivery, a carrier flow rate Q.sub.c, a drug flow rate Q.sub.d, a drug delivery rate dd, a target drug delivery rate dd.sub.target, a steady state rate ss, maximum allowable carrier flow Q.sub.cmax, a target steady state carrier flow Q.sub.css, drug flow rate at steady state Q.sub.dss);
controlling each of the infusion pumps provided with the first liquid based on the parameter information of each first liquid (step 340, 370, 390; col.17 ll.24-26); and
controlling each of the infusion pumps provided with the second liquid based on the parameter information of each second liquid (col.18 ll.12-end).
Regarding claim 3, Peterfreund teaches all the limitations of the claimed invention as discussed above. Peterfreund further teaches the step of determining the infusion attribute information includes determining the infusion attribute information based on input information received from the input device (col.15 ll.33-36 and col.16 ll.1-4; e.g. via 115).
Regarding claim 4, Peterfreund teaches all the limitations of the claimed invention as discussed above. Peterfreund further teaches the infusion attribute information further includes proportional information associated with the at least one second fluid (stock drug concentration is a proportion; col.16 ll.1-11).
Regarding claim 6, Peterfreund teaches all the limitations of the claimed invention as discussed above. Peterfreund further teaches adjusting the parameter information of each first liquid and of each second liquid according to received update information of the first liquid or the second liquid (required for 370; col.17 ll.9-26);
controlling each of the infusion pumps provided with the first liquid based on the adjusted parameter information of each first liquid (370; Fig 1); and
controlling each of the infusion pumps provided with the second liquid based on the adjusted parameter information of each second liquid (370; Fig 1).
Regarding claim 9, Peterfreund teaches all the limitations of the claimed invention as discussed above. Peterfreund further teaches automatically adjusting a relative proportion of each of the first and second liquids included in the total intake and delivered to a patient by the infusion pumps to correspond with desired proportion indicated though input by a user (col.17 ll.9-45).
Regarding claim 10, Peterfreund teaches an electronic device (110,115, 500, col.28 ll.26-43), comprising a processor (510) and a memory (520) in communication with the processor, wherein the memory stores computer-executable instructions and the processor is configured to execute the computer-executable instructions to cause the processor to: determine infusion attribute information (col.28 ll.26-43; e.g. at 320, Fig 3, col.16 ll.1-18), wherein the infusion attribute information includes a total intake of at least one first liquid and at least one second liquid for a predetermined time period (e.g. a target amount of drug to be delivered to the target, a carrier flow rate Q.sub.c, a drug flow rate Q.sub.d, a total flow rate Q.sub.T, a drug delivery rate dd, a target drug delivery rate dd.sub.target, a steady state rate ss, maximum allowable carrier flow Q.sub.cmax, a target steady state carrier flow Q.sub.css) and parameter information of each first liquid (first liquid may be either carrier fluid or drug; e.g. fa target amount of drug to be delivered to the target, a time of drug delivery, a carrier flow rate Q.sub.c, a drug flow rate Q.sub.d, a drug delivery rate dd, a target drug delivery rate dd.sub.target, a steady state rate ss, maximum allowable carrier flow Q.sub.cmax, a target steady state carrier flow Q.sub.css, a stock drug concentration c.sub.d);
determine parameter information of each second liquid based on the infusion attribute information (the second liquid is either a carrier fluid or a drug that is not being interpreted as the first liquid; determination based on the infusion attribute information may include merely selecting, viewing, or using any of the attribute information data points that are related to the second fluid; or the parameter information of each second liquid may be any other relevant parameter that is calculated from other values, per col.16 ll.11-13, 24-26 “Some of these parameters can be calculated from other parameters” and “the initial flow parameters are determined as a combination of received and calculated values”),
wherein the parameter information of a liquid includes at least two of the intake information, flow rate information and time information (e.g. a target amount of drug to be delivered to the target, a time of drug delivery, a carrier flow rate Q.sub.c, a drug flow rate Q.sub.d, a drug delivery rate dd, a target drug delivery rate dd.sub.target, a steady state rate ss, maximum allowable carrier flow Q.sub.cmax, a target steady state carrier flow Q.sub.css, drug flow rate at steady state Q.sub.dss);
control each of the infusion pumps provided with the first liquid based on the parameter information of each first liquid (step 340, 370, 390; col.17 ll.24-26); and
control each of the infusion pumps provided with the second liquid based on the parameter information of each second liquid (col.18 ll.12-end).
Regarding claim 12, Peterfreund teaches all the limitations of the claimed invention as discussed above. Peterfreund further teaches the processor is configured to determine the infusion attribute information based on information received from the input device (col.15 ll.33-36 and col.16 ll.1-4; e.g. via 115).
Regarding claim 13, Peterfreund teaches all the limitations of the claimed invention as discussed above. Peterfreund further teaches the infusion attribute information further includes proportional information associated with the at least one second fluid (stock drug concentration is a proportion; col.16 ll.1-11).
Regarding claim 15, Peterfreund teaches all the limitations of the claimed invention as discussed above. Peterfreund further teaches the processor is further configured to:
adjust the parameter information of each first liquid and each second liquid according to received update information of the first liquid or the second liquid (required for 370; col.17 ll.9-26);
control each of the infusion pumps provided with the first liquid based on the adjusted parameter information of each first liquid (370; Fig 1); and
control each of the infusion pumps provided with the second liquid based on the adjusted parameter information of each second liquid (370; Fig 1).
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.
Claims 2, 7-8, 11, and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peterfreund in view of the Harvard 2 infusion pump (Harvard Clinical Technology, Inc., 510(K) Summary K050107, 11 February 2005, Department of Health and Human Services, Food and Drug Administration).
Regarding Claim 2, Peterfreund teaches all the limitations of the claimed invention as discussed above. Peterfreund further teaches a drug-library or a database for storing drug related parameters in order to determine corresponding pre-defined safety ranges of the drug (col.3 ll.43-49, col.9 ll.47-60, col.15 ll.43-48, col.16 ll.2-4). Thus, Peterfreund teaches the step of determining infusion attribute information comprises: receiving at least one item of ingredient information and corresponding parameter information of the first or second liquid and determining the parameter information of each first liquid based on the received parameter information.
Peterfreund does not clearly teach identifying a liquid type as either one of the at least one first liquid or one of the at least one second liquid by comparing its ingredient information with a preset liquid table.
However, the Harvard 2 infusion pump discusses using a laser scanning barcode reader to scan a label placed on the syringe which selects a drug from the pump's resident drug library. This allows the pump to retrieve from its internal memory the drug's specific parameters such as concentration, infusion rate etc. in an effort to minimize user input errors (p.14, last two paragraphs). Thus, the Harvard 2 teaches identifying a liquid type as either one of the at least one first liquid or one of the at least one second liquid by comparing its ingredient information with a preset liquid table.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Peterfreund to include the barcode scanning feature of the Harvard 2 in order to minimize user input errors (p.14, last two paragraphs).
Regarding Claim 7, Peterfreund in view of Harvard 2 teaches all the limitations of the claimed invention as discussed above. Peterfreund further teaches outputting the ingredient information of the first liquid and one or more of the parameter information of the first liquid (col.3 ll.42-48).
Regarding Claim 8, Peterfreund in view of Harvard 2 teaches all the limitations of the claimed invention as discussed above. Peterfreund further teaches outputting the ingredient information of the second liquid and one or more of the parameter information of the second liquid (col.3 ll.42-48, col.4 ll.17-19).
Regarding Claim 11, Peterfreund teaches all the limitations of the claimed invention as discussed above. Peterfreund further teaches a drug-library or a database for storing drug related parameters in order to determine corresponding pre-defined safety ranges of the drug (col.3 ll.43-49, col.9 ll.47-60, col.15 ll.43-48, col.16 ll.2-4). Thus, Peterfreund teaches the processor is configured to receive infusion attribute information by receiving at least one item of ingredient information and its corresponding parameter information, and determining the parameter information of each first liquid based on the received parameter information.
Peterfreund does not clearly teach determining a liquid as a first liquid or a second liquid by comparing its ingredient information with a preset liquid table.
However, the Harvard 2 infusion pump discusses using a laser scanning barcode reader to scan a label placed on the syringe which selects a drug from the pump's resident drug library. This allows the pump to retrieve from its internal memory the drug's specific parameters such as concentration, infusion rate etc. in an effort to minimize user input errors (p.14, last two paragraphs). Thus, the Harvard 2 teaches determining a liquid as a first liquid or a second liquid by comparing its ingredient information with a preset liquid table.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Peterfreund to include the barcode scanning feature of the Harvard 2 in order to minimize user input errors (p.14, last two paragraphs).
Regarding Claim 16, Peterfreund in view of Harvard 2 teaches all the limitations of the claimed invention as discussed above. Peterfreund further teaches the processor is further configured to output the ingredient information of the first liquid and one or more of the parameter information of the first liquid (col.3 ll.42-48).
Regarding Claim 17, Peterfreund in view of Harvard 2 teaches all the limitations of the claimed invention as discussed above. Peterfreund further teaches the processor is further configured to output the ingredient information of the second liquid and one or more of the parameter information of the second liquid (col.3 ll.42-48, col.4 ll.17-19).
Claims 5 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peterfreund in view of McTaggart 8894631 and Stern 6063051.
Regarding claims 5 and 14, Peterfreund teaches all the limitations of the claimed invention as discussed above. Peterfreund further teaches the infusion pump(s) may be roller-type pump(s).
Peterfreund does not teach the infusion pump is provided with a timer, and the method further includes determining the infused amount of each first liquid and the infused amount of each second liquid based on the timer.
However, McTaggart teaches providing a master clock or timer for each pump in a multiple pump infusion system (col.6 ll.31-35).
And Stern teaches “[s]everal different mechanisms for measuring input fluid volumes are possible” including “a roller-pump 14b operating at a predetermined flow rate coupled with a timer in the digital computer 12” (col.5 ll.32-35).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Peterfreund to use timers to measure input fluid volumes as taught by McTaggart and Stern, because Stern teaches the method is applicable to roller pumps (such as those of Peterfreund; col.5 ll.32-35), in order to coordinate the pumps with each other (McTaggart, col.6 ll.31-36). Note, it has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, using the input fluid volume calculation method of Stern to determine input fluid volume by the roller pumps of Peterfreund, yielded the predictable result of determining input fluid volume for the roller pumps of Peterfreund
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE SEBASCO CHENG whose telephone number is (469)295-9153. The examiner can normally be reached 0600-0900 AM ET M-F and 1-2PM T/R.
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/STEPHANIE SEBASCO CHENG/Primary Examiner, Art Unit 3741
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