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 .
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.
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: pump mechanism in claims 1 and 11 interpreted as an infusion pump, ambulatory insulin pump, or known equivalents.
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 1-19 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 1, the limitation “a meal” at line 9 renders the claim indefinite because its unclear if this is the same as the meal claimed at line 7 or not.
Regarding claim 5, the limitation “wherein the total daily insulin value on insulin delivery history for the user” renders the claim indefinite because the limitation is a sentence fragment and it is unclear what is being claimed. Claim 14 contains the same limitation.
Regarding claim 8, the limitation “a user” renders the claim indefinite because its unclear if this is the same user previously claimed or not. Additionally, the limitation “a number of carbohydrates for calculation of the bolus” renders the claim indefinite because its unclear how the calculation of the bolus can occur without the estimated number of carbohydrates of the meal while entering the number of carbohydrates to calculate the bolus. Lastly, its unclear if the limitation “a bolus” renders the claim indefinite because its unclear if this is the meal bolus previously claimed or not. Claim 17 contains the same recitation.
Regarding claim 9, the limitation “a glucose level or a number of carbohydrates” renders the claim indefinite because its unclear whether this is the same as claimed in claim 8 or not. Claim 18 contains the same defect related to claim 17.
Regarding claim 11, the limitation “a predetermined amount of insulin” and “a meal bolus” in lines 8-9 render the claim indefinite because its unclear if this is the same as previously claimed in lines 6-7.
Claims dependent thereon are rejected for the same reasons.
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.
Claim(s) 1-2, 4-11, 13-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen US 2020/0342974.
Regarding claim 1, Chen discloses a system for closed loop diabetes therapy, see title, comprising: a pump mechanism, see fig. 2, element 12, configured to facilitate delivery of insulin to a user, see para. [0063]; a user interface, see fig. 2, element 20; at least one processor functionally linked to the pump mechanism and the user interface, see para. [0067] stating the controller 24 includes at least one processor that governs the pump and receives data from a UI; the at least one processor configured to: receive an indication from a user through the user interface that the user is going to consume a meal, see para. [0066] states that the UI has buttons or switches to announce events such as a meal; and cause the pump mechanism to deliver a predetermined amount of insulin to the user as a meal bolus in response to the indication that the user is going to consume a meal, see para. [0071] stating the pump may deliver medicine including a meal bolus dose, wherein the predetermined amount of the meal bolus is not determined based on an estimated number of carbohydrates in the meal, see para. [0168] stating the meal bolus preliminary value may be determined by the carbohydrate content of the meal divided by the ICR, where the carbohydrate content may be explicitly entered at the UI or may be inferred by the controller from meal data supplied at the UI. Additionally the carbohydrate content of the meal may be a qualitative judgment of the user by indicating a meal size such as small, medium, large or snack. Since the carbohydrate amount determining the meal bolus is indicated by the meal size and not the actual carbohydrate amount, the predetermined meal bolus is interpreted as not being based on the estimated number of carbohydrates in the meal but rather the meal size. This interpretation is consistent with the Applicant’s disclosure stating that rather carbohydrate counting, the easy bolus module provides an algorithm rather than requiring a user estimate.
Regarding claim 2, Chen discloses the predetermined amount of insulin is based on a total daily insulin value for the user. See para. [0169] stating the meal bolus is limited to less than a predefined fraction of the total daily insulin.
Regarding claim 4, Chen discloses a memory and wherein the total daily insulin value for the user is preprogrammed into the memory. See para. [0067] stating that the controller has memory, para. [0070] stating the TDD is stored in the memory.
Regarding claim 5, as best understood, Chen discloses the total daily insulin value on insulin delivery history for the user. See para. [0130] stating the TDD may be updated during use.
Regarding claim 6, Chen discloses the total daily insulin value for the user is updated at regular intervals based on subsequent insulin delivery. Id. stating the TDD are updated by the controller to average the insulin delivered each day over two weeks.
Regarding claim 7, Chen discloses the at least one processor is further configured to determine if the user’s glucose level is predicted to be below a low glucose threshold within a predetermined period of time of receiving the indication that the user is going to consume a meal and, if so, to reduce the predetermined amount. See para. [0166] stating that the meal bolus is determined from the carbohydrates in the meal, the ICR and the bolus attenuation factor, where the bolus attenuation factor reduces the meal bolus when the physiological glucose is relatively low or decreasing in value and is determined by the MMPC algorithm, the MMPC algorithm provides a prediction to a low physiological glucose and reduces the meal bolus, such calculation must occur within a period of time before a meal.
Regarding claim 8, as best understood, Chen discloses the at least one processor is configured to display a bolus calculator on the user interface that enables a user to enter one or more of a glucose level or a number of carbohydrates for calculation of the bolus. See para. [0066] stating the UI allows for input user data by buttons, etc. to announce events, like meals, exercise, etc, and the user interacts with information presented in menus, para. [0168] stating that the carbohydrate content of a meal may be explicitly entered at the UI for calculating the meal bolus.
Regarding claim 9, Chen discloses the at least one processor to display an option on the bolus calculator that will cause the predetermined amount to be delivered without entering a glucose level or a number of carbohydrates. Id. stating that the UI may allow the user to indicate a size of the meal by categories such as small, large, snack and thus allows the user to press an option on the bolus calculator to deliver the bolus without entering glucose or carbohydrates number.
Regarding claim 10, Chen discloses the indication that the user is going to consume the meal is selection of the option. Id. stating that the meal bolus is dependent on the UI input for the carbohydrate content in order to generate the meal bolus and thus the selection of the meal size, or input of carbohydrates is interpreted as the indication that a meal will be consumed since the input generates the meal bolus value.
Regarding claim 11, Chen discloses a system for closed loop diabetes therapy, comprising: a pump mechanism configured to facilitate deliver of insulin to a user, a user interface, at least one processor functionally linked to the pump mechanism and the user interface, the at least one processor configured to: cause the pump mechanism to deliver a predetermined amount of insulin to the user as a meal bolus in response to the indication that the user is going to consume a meal; and deliver a predetermined amount of insulin calculated based on a total daily insulin value for the user to the user as a meal bolus. Referring to claims 1 and 2, as best understood, Chen discloses all elements.
Regarding claims 13-19, referring to claims 4-10, Chen discloses all elements.
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 (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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 3 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view Booth US 2016/0117481.
Regarding claims 3 & 12, Chen discloses all elements except the predetermined amount of insulin is a fixed percentage of the total daily insulin value.
Booth teaches that patients on a consistent carbohydrate diet can be given a fixed carbs/meal dosage. See para. [0082]. Chen does teach that the meal bolus should be a percentage of the total daily dosage.
It would have been obvious to an ordinary skilled worker to provide an option for a fixed dosage based on the TDD for the meal bolus in the apparatus of Chen, as taught by Booth, in order to provide a selection for those patients with a consistent carbohydrate diet. Id.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The prior art is aware of calculating meal boluses without carbohydrate counting. See Mensinger US 2019/0392937 para. [0057]. Physiological prediction models using past user data are known. See Randlov US 2010/0280329 para. [0062]; Budiman US 2011/0224523 para. [0038]; Moberg US 2007/0255250 para. [0127]. Preprogrammed carbohydrate estimations are known. See US 2002/0107476 para. [0080]; Lebel US 2003/0050621 para. [0106].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GERALD LUTHER SUNG whose telephone number is (571)270-3765. The examiner can normally be reached 9-5 PST.
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/GERALD L SUNG/Primary Examiner, Art Unit 3741
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