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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 11-16, 20-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 11 recites the limitation “a predetermined amount of insulin not based on information pertaining to a specific meal”. The specification makes clear the predetermined amount of insulin is not based on a number of carbohydrates estimated for a specific meal only and does not discloses all other information pertaining to a specific meal. The Examiner finds no other discussion of excluding information of a specific meal when determining the amount of insulin to bolus.
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, 4-10 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 amount 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 is based on an 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 a bolus based on one or more of the glucose level or the number of carbohydrates. 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.
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) 11, 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view Holtzclaw US 2007/0255348.
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. Chen discloses the carbohydrate content of a meal may be explicitly entered at the user interface or may be inferred by the computer from a qualitative judgment of the user such as small, medium, large or snack descriptions of a meal. See para. [0168]. Chen does not expressly show a display, on the user interface, a bolus calculator, the bolus calculator including a first input region configured to receive meal information for determining a meal bolus based on the meal information and a second input region selectable to deliver a predetermined amount of insulin not based on information pertaining to a specific meal; and in response to selection of the second input region cause the pump mechanism to deliver the predetermined amount of insulin to the user.
Hotzclaw teaches a user interface having a first region configured to receive meal information for determining a meal bolus based on meal information, see manual bolus, para. [0134] stating that the icon allows the user to deviate from the default bolus values, and a second input region selectable to deliver a predetermined amount of insulin not based on information pertaining to a specific meal. Holtzclaw provides the UI with selectable menu icons to allow the user to have options. Id. Hotzclaw in addition states that the set bolus allows the user to program the device for a specific bolus value or values which correspond to various meals carbohydrate values commonly consumed by the user. Id. Thus, the amount of the set bolus is not specific to the meal about to be consumed but based on the user’s history.
It would have been obvious to an ordinary skilled worker to provide a UI having a first and second region as claimed in the UI of Chen, as taught by Hotzclaw, in order to provide the user with options. Id. Additionally, Chen teaches that the user should be able to count carbohydrates of a meal or select information that is representative of the carbohydrates. See para. [0168].
Regarding claims 13-16, referring to claims 4-10, Chen discloses all elements.
Regarding claim 20, 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 21, Chen, in view of Hotzclaw, discloses all elements including the at least one processor is configured to cause the pump mechanism to deliver the predetermined amount of insulin to the user automatically following a single user input received at the second input region. Hotzclaw teaches the set bolus icon allows for the dose selection, the single user input is interpreted as the last button required to deliver the bolus.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view Booth US 2016/0117481.
Regarding claims 1, 3, 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.
Regarding claims 1-10, referring to claim 3, 12, when Chen, in view of Booth, utilize a fixed carbs/meal dosage, the predetermined amount of the meal bolus is not determined based on an estimated amount of carbohydrates in the meal. Claims 1-10 rejected over Chen above discloses all other elements.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view Hotzclaw and Booth US 2016/0117481.
Regarding claim 12, Chen, in view of Hotzclaw and Booth discloses all elements referring to claim 3.
Claim(s) 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view Holtzclaw and Blomquist US 2003/0160683.
Regarding claims 21-22, Chen, in view of Holtclaw, discloses all elements including the at least one processor is configured to cause the pump mechanism to deliver the predetermined amount of insulin to the user automatically following a single user input received at the second input region but does not expressly teach the at least one processor is further configured to displace a confirmation prompt following selection of the second input region.
Blomquist teaches a UI that has a deliver button 384 for selecting and delivering a bolus which is followed by a confirmation banner 404 with a stop button 406. The confirmation banner provides a visual confirmation to the user and an opportunity to abort the delivery. See fig. 19 for example.
It would have been obvious to an ordinary skilled worker to provide a button do deliver the bolus dose and a confirmation banner to visually confirm the dose including an opportunity to end the dose in the user interface of Chen, in view of Holtzclaw, as taught by Blomquist, in order to provide visual confirmation and an opportunity to end the delivery. Id.
Response to Arguments
Applicant's arguments filed 8/3/2026 have been fully considered but they are not persuasive in part, and moot, in part.
The Applicant argues that Chen’s relied upon input is a meal specific information therefore does not meet the limitation “is not based upon an estimated amount of carbohydrates in the meal”. The Examiner disagrees. The Applicant’s specification states that a simpler alternative to a traditional meal bolus that does not require carbohydrate counting and enables a user to more quickly bolus for a meal with a lower cognitive burden. The simpler solution executes an algorithm rather than requiring the user to estimate carbohydrates in a given meal, assumes the meal requires a predetermined amount of insulin. By selecting a meal size, the algorithm of Chen assumes an amount of insulin required without the user actually estimating the number of carbohydrates in that meal. Thus, the selection of meal size does not constitute an estimation of the amount of carbohydrates consistent with the claimed limitation.
Furthermore, even arguendo, that the interface cannot consider any information about the meal, Booth teaches a fixed dosage applied to those people who are on a consistent diet. The fixed dosage does not include any information about the meal being consumed at the specific time, but rather is based on the habits of the user and therefore is not based on a calorie count of the meal being consumed.
Additionally, with regard to the amendments of claim 11, the arguments are considered moot in view of the new rejection. The Examiners notes that the Applicant appears to argue that no information about the meal may be considered when provided the bolus dose which does not appear to be supported in the claims for the reasons discussed above. Nevertheless, the prior art Holtzclaw teaches that a set bolus can be used based on prior habits and Booth as well teaches a fixed dose may be applied which is consistent with the Applicant’s disclosure.
For these reasons, the Examiner disagrees with the Applicant’s arguments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Devon Kramer can be reached at (571)272-7118. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GERALD L SUNG/Primary Examiner, Art Unit 3741
