DETAILED ACTION
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.
Claim Objections
Claim 10 is objected to because of the following informalities: line 3 should be amended to -configured to store a computer-executable [[instruction]] instructions;-. 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.
The following claim limitations
infusion module (claim 9)
determination module (claim 9)
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 (infusion module - claim 9)
module (determination module - claim 9)
coupled with functional language
module (infusion module - claim 9)
module (determination module - claim 9)
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) 9 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:
see the 35 USC 112(b) rejection below (infusion module - claim 9)
see the 35 USC 112(b) rejection below (determination module - claim 9)
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 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.
Claim 9 is 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 claim limitations “infusion module” and “determination module” in lines 2 and 4 respectively have been interpreted to invoke 35 USC 112(f) however the applicant has failed to provide any corresponding structure in the specification for these limitations. For this reason, the limitations are unclear and by extension the claim as well. For the sake of examination, the office has interpreted these limitations to refer to parts of a program or computer/controller that calculates or determines the steps outlined in the claim.
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.
Claims 1-4, 7-13 and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20160354543 A1 to Cinar et al. (Cinar).
Cinar discloses:
Regarding claim 1:
A method (figures 1-2) for controlling an infusion device (“pump” or 50 in figures 1 and 2), comprising:
infusing a target object (patient 22) according to a set infusion parameter (data/signal sent form 46/40 to the pump 50 during an initial or early operation of the system of 20 operates the pump 50), and acquiring a current first physiological parameter (30/36) of the target object (22); and
determining a target infusion parameter (the insulin infusion rate sent from 46 to pump 50 when the unsafe glucose amount is detected as mentioned in ¶0044) according to a target parameter (data from biometric sensor 36 or glucose sensor 36) when the first physiological parameter falls outside of a preset range of physiological parameters (period of time when the glucose level is high as mentioned in ¶0044), and automatically switching the infusion device (50) to infuse the target object (patient 22) according to the target infusion parameter (pump actuated according to the insulin infusion rate as mentioned in ¶0044), wherein the target parameter comprises at least one of: the first physiological parameter (biometric sensor data or glucose sensor date as shown in figure 1), a weight of the target object, and a constant infusion parameter.
Regarding claim 2:
The method of claim 1, wherein the step of infusing the target object (22) according to the set infusion parameter comprises:
infusing the target object (22) according to the set infusion parameter (data/signal sent form 46/40 to the pump 50 during an initial or early operation of the system of 20 operates the pump 50) when the infusion device (50) enters a first operating mode (initial or early operation of system 20);
the step of determining the target infusion parameter according to the target parameter comprises:
determining a second operating mode (later operation of the system 20 when its operating during aerobic exercise and shown in figure 3) to be switched by the first operating mode, and running the second operating mode (the system 20 operating during aerobic and anaerobic exercise); and
determining the target parameter (data from biometric sensor 36 or glucose sensor 36) according to the second operating mode (data from the sensor during aerobic or anaerobic exercise), and determining the target infusion parameter according to the target parameter (data/signal sent form 46/40 to the pump 50 during aerobic or anaerobic exercise).
Regarding claim 3:
The method of claim 1, wherein the step of determining the target infusion parameter according to the target parameter comprises:
acquiring a physiological characteristic (glucose measurement from the sensor 30 or biometric measurement from the sensor 36) of the target object (22);
obtaining a target model (either “desired future trajectory” from 42 or the “recursive update of model parameters” 44) matched to the physiological characteristics (both receive data from the glucose sensor and 44 receivers the glucose sensor and the biometric sensor); and
inputting the target parameters into the target model (control module 46 receives the information from the target models 42/44), and obtaining the target infusion parameters output from the target model (the target infusion is sent from 46 to pump 50).
Regarding claim 4:
The method of claim 1, wherein after the step of infusing the target object (22) according to the target infusion parameters, the method further comprises:
acquiring a second physiological parameter (sensor data from 36 of 30 on a following iteration/loop of operation of the system 20) of the target object (22); and
infusing the target object (22) according to the set infusion parameter when the second physiological parameter is in the preset range of the physiological parameters (sending signal form control module 46 to the pump 50 when the glucose level is safe as indicated in ¶0044).
Regarding claim 7:
The method of claim 1, wherein the step of acquiring the current first physiological parameter of the target object (22) comprises:
sending an acquisition request (see the request A in figure 1 below) of a physiological parameter (“predicted blood glucose”) to an acquisition device (44) of the physiological parameter, wherein the acquisition device is configured to acquire the physiological parameter (data from the sensors 36/30) of the target object (22); and
receiving the current first physiological parameter (current “predicted blood glucose”) of the target object (22) sent by the acquisition device (44).
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430
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Figure 1 – figure 1 of Cinar, annotated by the examiner
Regarding claim 8:
The method of claim 1, wherein the step of acquiring the current first physiological parameter of the target object (22) comprises:
acquiring a physiological characteristic (data from sensors 36/30) of the target object (22); and
inputting the physiological characteristic (data from sensors 36/30) and the set infusion parameters (infusion parameter from loop A in figure 1 above) into a prediction model (44 uses recursive modeling as indicated in ¶0043) to obtain the current first physiological parameter (“predicted blood glucose”) of the target object (22) output by the prediction model.
Regarding claim 9:
An infusion device (50), comprising:
an infusion module (portion of the control module 46 that sends the infusion data to the pump 50 and receives the physiological parameter “predicted blood glucose” from 44) configured to infuse a target object (22) according to a set infusion parameter (control of pump 50), and acquire a current first physiological parameter of the target object (22)(received from 44); and
a determination module (portion of the control module 46 that receives the desired future trajectory form 42 and determines the operation of pump 50) configured to determine a target infusion parameter (the insulin infusion rate sent from 46 to pump 50 when the unsafe glucose amount is detected as mentioned in ¶0044) according to a target parameter (data from biometric sensor 36 or glucose sensor 36) when the first physiological parameter falls outside of a preset range of physiological parameters (period of time when the glucose level is high as mentioned in ¶0044), and automatically switching the infusion device (50) to infuse the target object (22) according to the target infusion parameter (pump actuated according to the insulin infusion rate as mentioned in ¶0044), wherein the target parameter comprises at least one of: the first physiological parameter (biometric sensor data or glucose sensor date as shown in figure 1), a weight of the target object (22), and a constant infusion parameter.
Regarding claim 10:
An infusion device (50) comprising:
a memory and a processor (“The controller includes a processor and the necessary recordable medium to store and execute a prediction module” ¶0013);
said memory being configured to store a computer-executable instruction (“The controller 40 includes a processor in combination with a recordable medium for implementing the control model according to this invention” ¶0042); and
said processor being configured to execute the computer-executable instructions stored in the memory (“The controller 40 includes a processor in combination with a recordable medium for implementing the control model according to this invention” ¶0042), such that the processor is caused to control the infusion device (50) by:
infusing a target object (22) according to a set infusion parameter, and acquiring a current first physiological parameter of the target object (22); and
determining a target infusion parameter (the insulin infusion rate sent from 46 to pump 50 when the unsafe glucose amount is detected as mentioned in ¶0044) according to a target parameter (data from biometric sensor 36 or glucose sensor 36) when the first physiological parameter falls outside of a preset range of physiological parameters (period of time when the glucose level is high as mentioned in ¶0044), and automatically switching the infusion device (50) to infusing the target object (22) according to the target infusion parameter (pump actuated according to the insulin infusion rate as mentioned in ¶0044), wherein the target parameter comprises at least one of the first physiological parameter (biometric sensor data or glucose sensor date as shown in figure 1), a weight of the target object, and a constant infusion parameter.
Regarding claim 11:
All limitations of the claim are taught by the 35 USC 102 rejection of claim 2 by Cinar.
Regarding claim 12:
All limitations of the claim are taught by the 35 USC 102 rejection of claim 3 by Cinar.
Regarding claim 13:
All limitations of the claim are taught by the 35 USC 102 rejection of claim 4 by Cinar.
Regarding claim 16:
All limitations of the claim are taught by the 35 USC 102 rejection of claim 7 by Cinar.
Regarding claim 17:
All limitations of the claim are taught by the 35 USC 102 rejection of claim 8 by Cinar.
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.
Claim(s) 5, 6, 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20160354543 A1 to Cinar et al. (Cinar) as applied to claims 1 and 10 above, and further in view of US 20180085520 A1 to Ledford et al. (Ledford).
Regarding claim 5:
Cinar fails to disclose:
The method of claim 1, wherein before the step of infusing the target object according to the set infusion parameter, the method further comprises:
outputting a control page; and
when detecting a completion operation of an infusion parameter triggered on the control page, obtaining an input infusion parameter according to the completion operation, and determining the set infusion parameter according to the input infusion parameter.
Ledford teaches:
An infusion device (200) that includes a user interface/control page (230) for controlling the infusion pump (210). Further, a completion time/operation is defined by the user inputs on the control page (target delivery time defined by the user as indicated in ¶0064) and further rate limit (“input infusion parameter”) can be determined by the user (¶0064). Further, the infusion parameter (or control of the pump) can then be derived from the above parameters (¶0064 -0065).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Cinar to further include a control page for defining the completion operation based on an infusion parameter defined on a control page and further determining the infusion parameter (input on the control page) and the set infusion parameter of the pump based infusion parameter as taught by Ledford to control the pump and the and delivery times of the medication without the help of a clinician (¶0010).
Regarding claim 6:
Cinar fails to disclose:
The method of claim 1, further comprising:
outputting a setting page of a range of physiological parameters; and
when detecting a setting operation of the range of physiological parameters in the setting page, obtaining an input physiological parameter according to the setting operation, and setting a preset range of physiological parameter according to the input physiological parameter.
Ledford teaches:
An infusion device (200) that includes a user interface/setting page (230) for controlling the infusion pump (210). Further, a completion time/operation is defined by the user inputs on the setting page (input physiological parameter defined by the user as indicated in ¶0064) and further rate limit (“input infusion parameter”) can be determined by the user (¶0064). Further, the infusion parameter (or control of the pump) can then be derived from the above parameters (¶0064 -0065).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Cinar to further include a setting page for setting the completion time and the rate limit (“input physiological parameter”) of the pump and the pump infusion rate (preset range of physiological parameter) is determined and the pump is controlled accordingly as taught by Ledford to control the pump and the and delivery times of the medication without the help of a clinician (¶0010).
Regarding claim 14:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 5 by Cinar and Ledford.
Regarding claim 15:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 6 by Cinar and Ledford.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following is pertinent prior art:
US-20080262469-A1
Brister
See the infusion device 10
US-20170049963-A1
Varsavsky
See the control process as shown in figure 2
EP-2711036-A1
FONTANAZZI
See the control process as shown in figure 2
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WESLEY G HARRIS/Examiner, Art Unit 3783
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