DETAILED ACTION
The Applicant’s response, received 13 August 2025 has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 .
Status of the Claims
Claims 1-10 are pending.
Claims 3, 5, 6, 9, and 10 are withdrawn.
Claims 1, 2, 4, 7, and 8 are rejected.
Priority
Claims 1, 2, 4, 7, and 8 are given benefit to the claim for priority to Provisional Application No. 62/069,195, filed 27 October 2014.
Claim Interpretation
The claim limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, in the Office action mailed 26 February 2025 are maintained in view of the amendment received 13 August 2025 and reiterated below.
Claim 1 recites the limitation “dosing controller.” This limitation is interpreted to mean a computing device with non-transitory memory that retrieves and stores information from a glucometer, and determines insulin doses and dosing parameters based on the received blood glucose measurement (specification, at ¶ [0075]; and FIG. 1B, reference no. 160).
Claim 1 recites the limitation “wherein the correction dose of rapid-acting insulin is to be administered to the patient in addition to administration of the recommended planned basal dosage of long-acting basal insulin to the patient” in the “calculating a correction dose” step. This limitation is interpreted be an intended use limitation, i.e., the correction dose is intended to be administered with the planned basal dosage, but the claim doesn’t administer the planned basal dosage because the system does not control the administration device to administer the planned basal dosage.
Claim 1 recites the limitation “a recommended planned basal dosage of long-acting basal insulin to be administered to the patient at a pre-determined pre-meal time” at the “obtaining” step, however the claim only requires the step of obtaining the recommended planned basal dosage of long-acting basal insulin because “to be administered to the patient at a pre-determined pre-meal time” is an intended use of the obtained information.
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 is:
“an administration device configured to administer doses of insulin” in independent claim 1.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The written description discloses a corresponding structure for:
“an administration device configured to administer doses of insulin” at ¶ [0076] in the specification (the administration device 123 may include the insulin pump 123a or the pen 123b); and FIGS. 1B & 1C at reference Nos. 123a & 123b (insulin pump; or smart pen).
If applicant does not intend to have this limitation 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 to avoid it 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 recites sufficient structure to perform the claimed function so as to avoid it being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
The amendment received 13 August 2025 has been fully considered, however after further consideration, new grounds of rejection are raised in view of the amendment.
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.
(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.
Claims 1, 2, and 4 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Sloan et al. (US 2012/0232520, as cited in the Information Disclosure Statement (IDS) received 23 June 2023, newly cited).
Sloan et al. shows a multi-function analyte monitor device (Title) for providing a medication dosage calculation function (para. [0004]) for determining a recommended update to a long-acting insulin dosage regimen (para. [0018]; and FIG. 10); and further shows a long-acting medication may be a medication wherein a single dose may last for up to 12 hours, 24 hours, or longer, and if the current analyte concentration is above a predetermined threshold, the long-acting medication dosage calculation function may use the current analyte concentration value to calculate a recommended dosage of a long-acting medication (para. [0117]) and that periodic injection or administration of long-acting insulin may be used to maintain a baseline blood glucose concentration in a patient with Type-1 or Type-2 diabetes (para. [0118]).
Regarding claim 1, Sloan et al. shows a health monitor device with a medication dose calculation function that includes a controller unit operatively coupled to a communication interface and configured for bidirectional communication (para. [0060]); a drug administration system that includes an insulin pump (para. [0362] and FIG. 20); analyte level (e.g., glucose) determination (para. [0066] and FIG. 3); a data processing unit, display unit, data storage unit (paras. [0274] & [0275], and FIG. 20); obtaining user-specific data from a central data repository via a network communication (paras. [0393] – [0397]); a health monitor device configured to provide the user, e.g., automatically or in response to a user input, information relating to the user’s target blood glucose level, carbohydrate intake, and one or more correction factors or amounts (para. [0378]); calculating and displaying a recommended long-acting insulin dosage (para. [0124]); whenever the glucose measurement exceeds a high or low threshold, a correction bolus occurs based on glucose level and trending information (para. [0436]); a combination of a long-acting insulin and a rapid-acting insulin (para. [0182]); the adjusted dose level is displayed on the display unit (para. [0146]); calculating a medication dosage and/or calculating a recommended update to an existing medication dosage which may be displayed to the patient or further transmitted directly to a medication administration device such as an insulin pump (para. [0089]); and a transmitter/receiver unit used to transmit and/or receive analyzed or raw data or instructions t/from, for example, optional peripheral devices, such as a data analysis unit or a medication administration unit in a data network (para. [0082]).
Regarding claim 2, Sloan et al. shows a health monitor device may also include a strip port which may be configured for receiving a test strip for determining the concentration of glucose (para. [0085]).
Regarding claim 4, Sloan et al. shows the health monitor device may include a corresponding docking station that may include a transmitter whereby when the health monitor device is docked to the docking station, the health monitor device and docking station may communicate over a data network with, for example, a health care professional, for the transfer of data or receipt of instructions or new dosage regimens (para. [0195]).
Sloan et al. therefore anticipates the claimed invention.
Claim Rejections - 35 USC § 103
The rejection of claims 1, 2, 4, 7, and 8 under 35 U.S.C. 103 as being unpatentable over Shaya in view of King in view of Blomquist et al. in the Office action mailed 26 February 2025 is withdrawn in view of the amendment received 13 August 2025.
The amendment received 13 August 2025 has been fully considered, however after further consideration, new grounds of rejection are raised under 35 U.S.C. 103 in view of the amendment.
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.
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.
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 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Sloan et al. (US 2012/0232520, as cited in the Information Disclosure Statement (IDS) received 23 June 2023, and as cited above) as applied to claims 1, 2, and 4 above, and further in view of Shaya (US 2010/0262434, as cited in the Information Disclosure Statement (IDS) received 23 June 2023, and in the Office action mailed 26 February 2025) in view of King (US 2009/0036753, as cited in the Information Disclosure Statement (IDS) received 23 June 2023, and in the Office action mailed 26 February 2025) in view of Blomquist et al. (US 2008/0228056, as cited in the Information Disclosure Statement (IDS) received 23 June 2023, and in the Office action mailed 26 February 2025).
Regarding claim 7, Sloan et al. as applied to claims 1, 2, and 4 above, does not show aggregating one or more glucose measurements associated with a breakfast glucose time interval to determine a representative aggregate breakfast glucose measurement for the patient; aggregating one or more glucose measurements associated with a midsleep glucose time interval to determine a representative aggregate midsleep glucose measurement; selecting a governing glucose measurement as a lesser one of the representative aggregate midsleep glucose measurement or the representative aggregate breakfast glucose measurement; determining an adjustment factor for adjusting a next recommended basal dosage based on the selected governing glucose measurement; obtaining a previous day recommended basal dosage; and determining the next recommended basal dosage by multiplying the adjustment factor times the previous day recommended basal dosage.
Regarding claim 7, Shaya shows a method and apparatus to calculate diabetic sensitivity factors (i.e., correction factors, para. [0019]) affecting blood glucose (Title).
Shaya further shows that recorded data inputs can contain about a 100 data points corresponding to the number of meal intervals or events, and that this is adequate for aggregate and even segmented analyses limited to a specific meal of the day (para. [0109]); that the insulin pump stores a history of the actual insulin dose delivered, Ia, along with a timestamp (para. [0214]) and for an insulin pump to provide a calculation of sensitivity factors, the pump’s data storage would also retain the blood glucose readings, BG, the time of BG reading, and Carbs in addition to the routine storage of Ia, and that all of these data are routinely input to perform the Ir, calculation of bolus dosage (para. [0215]). Shaya further shows recording carbohydrate intake at each meal, insulin delivered, and blood glucose readings (BG) before meals and three to four hours after meals (BG2) and using an equation calculation provides ongoing best fits of the sensitivity factors to explain the changes observed in blood glucose (BG), and that the data can easily be segmented by meal type to permit more precise recommendations for each meal of the day, and that similarly, the data can be segmented for part of the week, sports participation, illness, etc., to see if the best-fit sensitivity factors are significantly affected by these segmentations (para. [108]); and using intervals (e.g., longer) in a span of time covering the dataset to provide data points for statistical analysis, and a number of data points adequate for aggregate and even segmented analyses limited to a specific meal of the day (para. [109]); and a spreadsheet embodiment in the form of a spreadsheet program that records necessary data to allow calculation of patient sensitivity factors and their confidence limits, with data entry fields for date, breakfast, lunch, dinner, and nighttime (paras. [0297] & [0300]; and FIG. 13).
Sloan et al. as applied to claims 1, 2, and 4 above, in view of Shaya does not show glucose measurements associated with a midsleep glucose time interval (claim 7), or determining the next recommended basal dosage by multiplying the adjustment factor times the previous day recommended basal dosage (claim 7).
Regarding claim 7, King shows a method for individualized management of diabetes in insulin-dependent patients comprising a period of evaluation as the patient adheres to a structured pattern of eating, sleeping, and physical activity (Abstract); continuous glucose monitoring-directed adjustments in basal insulin rate and insulin bolus dosing formulas (Title); glucose is monitored with a continuous glucose monitoring system, insulin doses are metered, carbohydrate consumption is quantified, and glucose, carbohydrate, and insulin data are collected and analyzed, and then the insulin dosage is adjusted in three steps: (1) an insulin dosage is estimated from conventional formulas, (2) adjustments are made according to the patient’s clinical specifics, and (3) further insulin dose adjustments are made according to glucose data obtained during the evaluation period (Abstract). King further shows the generation of continuous glucose-driven-insulin adjustments (CGIA) that are delivered to the patient’s insulin pump to achieve control of glucose to a near normal level (para. [0007]); a series of evaluation steps for establishing the basal rate that begin by dividing the basal dose into various appropriate time periods encompassing the day, where an exemplary series of daily time segments is represented by the four periods substantially defined by meal and sleep schedule: (1) breakfast to lunch, (2) lunch to dinner, (3) dinner to bed, and (4) bed to breakfast (para. [0104]); an elevated glucose reading during the time period 2300 to 0500 hours (i.e., midsleep; para. [0115]; and FIG. 8); and an insulin adjustment or evaluation period (para. [0029]) from which patient-specific mathematical constants that characterize the data are determined with regard to clinically appropriate levels of basal and bolus insulin dosages (para. [0030]), and wherein the evaluation period is of relatively short duration, i.e., a period of about four to seven days is typically sufficient, and by the end of the evaluation period, by which time substantially normal glucose values have been achieved, various quantitative relationships from accumulated data are calculated for an ensuing extended period of therapy, and through the implementation of appropriated insulin dosing, diabetic patients can achieve glucose profiles through the day that are substantially similar to those of non-diabetic people (para. [0031]). King further shows an embodiment where the patient interacts with a physician or health profession remotely via the internet, and where a health care professional expert in continuous glucose monitoring is remotely engaged, a patient gathers the information, transfers it electronically, via the internet, for example, and the data are then interpreted by the health care professional, who then makes changes in insulin treatment, and transmits such changes to the patient, or directly to the control systems that operate the patient’s insulin pump (para. [0038]). King further shows a method of treating a diabetic patient with an insulin dosage schedule clinically appropriate for that individual patient that is determined during an evaluation period, including determining a clinically appropriate basal insulin dosage and insulin bolus dosage and applying the insulin dosages to the patient for an ensuing period of insulin therapy (para. [0008]), and that the values obtained during the evaluation period provide clinically appropriate insulin dosages that remain constant typically over a period of at least several months (para. [0032]); embodiments provide for the patient being educated with regard to medical aspects of insulin treatment and further provided a conceptual understanding in the theory underlying the concept of basal bolus dosing (i.e., an intensive insulin therapy for diabetes that mimics the way a healthy pancreas releases insulin, by using two different types of insulin to manage blood sugar: a steady, long-acting (basal) dose and a rapid-acting (bolus) dose taken at mealtimes; e.g., paras. [0055], [0056], [0057], [0058], [0059], and [0060] in the Specification) and the medical desirability and benefits of glucose control that is as close to physiological ideal as possible (para. [0012]).
Sloan et al. as applied to claims 1, 2, and 4 above, in view of Shaya in view of King does not show determining the next recommended basal dosage by multiplying the adjustment factor times the previous day recommended basal dosage (claim 7).
Blomquist et al. shows basal rate testing using frequent blood glucose input (Title) and further shows an apparatus comprising a user interface configured to generate an electrical signal to start a basal insulin rate test when prompted by a user, an input configured to receive sampled blood glucose data of a patient that is obtained during a specified time duration, including a time duration during delivery of insulin according to a specified basal insulin rate pattern, and a controller communicatively coupled to the input and the user interface (Abstract).
Furthermore, Blomquist et al. shows that an insulin pump can provide a background or basal infusion of insulin throughout the day and provide a quick release or bolus of insulin when carbohydrates are eaten, and if a person develops high blood sugar, a correction bolus can be delivered by the pump to correct it (para. [0018]).
Regarding claim 7, Blomquist et al. shows the controller includes an insulin calculation module configured for determining at least one of an amount of basal insulin over-delivered and an amount of basal insulin under-delivered during the basal insulin rate test in trying to meet a target blood glucose baseline (Abstract). Blomquist et al. further shows that the insulin calculation module may adjust the correction factor before determining an amount of insulin under or over-delivered, and in certain embodiments, may use a correction factor multiplier to adjust the correction factor when determining the amount of insulin under or over-delivered, and consequently adjusting the amount of insulin in any recommended changes to the basal rate pattern (para. [0038]); and using a correction factor multiplier results in a lower amount of basal insulin allowing adjustments to be made more safely (para. [0039]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the methods of Sloan et al. as applied to claims 1, 2, and 4 above, by incorporating methods for aggregating data as shown by Shaya and discussed above. One of ordinary skill in the art would have been motivated to combine the methods of Sloan et al. with Shaya because Shaya shows the additional capability of aggregating data spanning a number of meal intervals or events. This modification would have had a reasonable expectation of success because both Sloan et al. as applied to claims 1, 2, 4, and 8 above, and Shaya disclose determining adjustment factors for recommended dosages.
It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the methods of Sloan et al. as applied to claims 1, 2, and 4 above, in view of Shaya by incorporating methods for the management of diabetes care in insulin-dependent subjects that monitors glucose levels continuously and makes insulin-dose adjustments accordingly to correct basal insulin rates as shown by King and discussed above. One of ordinary skill in the art would have been motivated to combine the methods of Sloan et al. in view of Shaya and King because King shows a method for testing the patient to determine the patient’s individualized carbohydrate-to-insulin ratio (CIR) and the correction factor (CF) during an evaluation period under conditions of controlled or structured daily activity, applying the CIR and CF to determine a clinically appropriate basal insulin dosage and insulin bolus dosage, and applying the insulin dosages to the patient for an ensuing period of insulin therapy. This modification would have had a reasonable expectation of success because both Sloan et al. as applied to claims 1, 2, and 4 above, in view of Shaya and King show a method for continuous glucose monitoring-directed adjustments in basal insulin rate and insulin bolus dosing formulas comprising a period of evaluation of the patient.
It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the methods of Sloan et al. as applied to claims 1, 2, 4, and 8 above, in view of Shaya in view of King by incorporating a method to achieve a target blood glucose baseline. One of ordinary skill in the art would have been motivated to combine the methods of Sloan et al. in view of Shaya in view of King with Blomquist et al. because Blomquist et al. shows a method and apparatus for basal rate testing using frequent blood glucose input obtained during a specified time duration. This modification would have had a reasonable expectation of success because both Sloan et al. as applied to claims 1, 2, and 4 above, in view of Shaya in view of King and Blomquist et al. show a method and apparatus for generating insulin dose adjustments to meet a target blood glucose baseline, and determining a recommended change, if any, to the basal insulin rate pattern.
Regarding claim 8, Sloan et al. shows a recommended fast-acting insulin dosage to be displayed on a display unit of the health monitor device (para. [0192]).
Response to Arguments
The Applicant’s arguments/remarks received 13 August 2025 have been fully considered, however they are not persuasive.
The Applicant states on page 5 (para. 3) of the Remarks that no combination of the prior references teaches or suggests “a recommended planned basal dosage of long-acting insulin to be administered to the patient at a predetermined pre-meal time,” and “calculating a correction dose of rapid-acting insulin…wherein the correction dose of rapid-acting insulin is to be administered to the patient in addition to administration of the recommended planned basal dosage of long-acting basal insulin to the patient,” as recited in independent claim 1.
This argument is not persuasive, because the Applicant’s argument does not take into account the newly cited Sloan et al. reference that is used in the above rejections.
The Applicant states on page 5 (para. 3) of the Remarks that the Office action conflates a basal dose of long-acting basal insulin with a correction dose of rapid-acting insulin.
This argument is not persuasive, because of the Applicant’s argument does not take into account the newly cited Sloan et al. reference that is applied in the above rejections.
The Applicant states on page 6 (para. 1) of the Remarks that King teaches away from the limitation “a recommended planned basal dosage of long-acting basal insulin to be administered to the patient at a pre-determined pre-meal time.”
This argument is not persuasive, because of the Applicant’s argument does not take into account the newly cited Sloan et al. reference that is applied in the above rejections.
The Applicant states on page 6 (para. 2) of the Remarks that an appropriate reference for rejecting claim 1 must have both “a recommended planned basal dosage of long-acting basal insulin to be administered to the patient at a pre-determined pre-meal time,” and “calculating a correction dose of rapid-acting insulin…wherein the correction dose of rapid-acting insulin is to be administered to the patient in addition to administration of the recommended planned basal dosage of long-acting basal insulin to the patient.” The Applicant further states that obviousness cannot be established by using the Applicant’s application as a template to fit together independent pieces of prior art, and accordingly, claims are not disjointed lists of elements, but present an invention that must be considered as a whole.
This argument is not persuasive, because of the Applicant’s argument does not take into account the newly cited Sloan et al. reference that is applied in the above rejections.
The Applicant states on page 6 (para. 3) of the Remarks that the Office action admits that Shaya and King do not, individually or in combination, teach or suggest determining a recommended basal dosage by multiplying an adjustment factor by the previous day’s recommended basal dosage, and that the Office action relies on Blomquist to overcome the admitted deficiencies of Shaya and King. The Applicant further states that while claim 1 recites a recommended planned basal dosage of long-acting basal insulin, claim 1 does not recite that the basal dosage is based on an adjustment factor, and further states that Blomquist is silent regarding any determination of a correction dose of rapid-acting insulin.
These arguments are not persuasive, because Blomquist is relied on in combination with the newly cited Sloan et al. reference in view of Shaya in view of King because the combination of Sloan et al. in view of Shaya in view of King does not show determining the next recommended basal dosage by multiplying the adjustment factor times the previous day recommended basal dosage (claim 7). Blomquist is not relied on to show any determination of a correction dose of rapid-acting insulin, however Blomquist is relied on to show the limitations not shown by Sloan et al. in view of Shaya in view of King, as discussed in the rejection above.
The Applicant states on page 7 (para. 2) of the Remarks that since a reference is only good for what it clearly and definitely discloses, a person of ordinary skill in the art would not have been led by the cited references, individually or in combination, to arrive at the claimed invention, because the references fail to disclose all of the claimed limitations.
This argument is not persuasive, because of the Applicant’s argument does not take into account the newly cited Sloan et al. reference that is applied in the above rejections.
Conclusion
No claims are allowed.
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.
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/S.W.B./Examiner, Art Unit 1687
/KAITLYN L MINCHELLA/Primary Examiner, Art Unit 1685
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