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 Objections
Claim 1 is objected to because of the following informalities: On line 8, the term “steps” should be inserted after the phrase “the following” in order for the phrase to be complete. On line 9, the term “the” in the phrase “the periodic intervals” should be deleted since this is the first time that this feature is being introduced. On line 10, the term “the” should be inserted before the term “medicament” because this feature has been introduced earlier in the claim. On line 12, the phrase “the selected periodic interval” should recite “[[the]] a selected periodic interval of the periodic intervals” since this is the first time that this feature is being introduced. On line 20, the term “the” in the phrase “the amount” should be replaced with the term “a” since this is the first time this feature is being introduced. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: On line 3, the term “the” should be inserted before the term “medicament” since this feature has been introduced earlier in the claim. On line 3, the term “medicament” should be inserted before the term “storage” to match the language used earlier in the claim. On line 6, the term “steps” should be inserted after the phrase “the following” in order for the phrase to be complete. On line 7, the term “the” in the phrase “the periodic intervals” should be deleted since this is the first time that this feature is being introduced. On line 9, the term “a” in the phrase “a medicament” should be replaced with the term “the” since this feature has been introduced earlier in the claim. . On lines 10-11, the phrase “the selected periodic interval” should recite “[[the]] a selected periodic interval of the periodic intervals” since this is the first time that this feature is being introduced. On lines 18-19, the term “produce” should be inserted before the phrase “a compensated basal dosage” in order to be grammatically correct. On line 20, the term “the” in the phrase “the magnitude” should be replaced with the term “a” since this is the first time this feature is being introduced. On line 21, the terms “increase” and “decrease” should be replaced with the terms “increasing” and “decreasing” to match the language used earlier in the claim. On line 23, the term “a” in the phrase “a threshold” should be replaced with the term “the” since this features has been introduced earlier in the claim. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: The phrase “which the compensated basal dosage is increased depends in part on much the temperature” is grammatically incorrect and should be amended to recite “which the compensated basal dosage is increased by depends in part on how much the temperature”. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: The phrase “which the compensated basal dosage is increased or decreased depends at least in part on an adjustment factor” is grammatically incorrect and should recites “which the compensated basal dosage is increased or decreased by depends at least in part on an adjustment factor”. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: The term “the” should be inserted before the term “medicament” on line 2 since this feature has been introduced earlier in the claims.
Claim 17 is objected to because of the following informalities: On line 4, the term “the” should be inserted before the term “insulin” since this feature has been introduced earlier in the claim. On line 4, the term “insulin” should be inserted before the term “storage” to match the language used earlier in the claim. On line 7, the term “steps” should be inserted after the phrase “the following” in order for the phrase to be complete. On line 8, the term “the” in the phrase “the periodic intervals” should be deleted since this is the first time that this feature is being introduced. On line 9, the term “medicament” should be replaced with the term “insulin” to match the language used earlier in the claim. On line 12, the term “a” in the phrase “a user” should be replaced with the term “the” since this feature has been introduced earlier in the claim. On line 16, the term “the” in the phrase “the predicted glucose level” should be replaced with the term “a” since this is the first time that this feature is being introduced. On line 17, the phrase “a compensated basal dosage of the medicament” should be replaced with the phrase “a compensated basal insulin dosage insulin dosage ” to match the language used earlier in the claim. On line 20, the term “insulin” should be inserted before the term “dosage” to match the language used earlier in the claim. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: The term “insulin” should be inserted after the term “basal” on line 3 in order to match the language used earlier in the claims. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: The term “insulin” should be inserted after the term “basal” on line 2 in order to match the language used earlier in the claims. Appropriate correction is required.
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 1-20 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.
Re claim 1: Line 14 recites the step of “determining how many periodic intervals have elapsed” and lines 20-21 recite that an amount of increasing/decreasing is “based on how many periodic intervals have elapsed”. It is unclear if these “periodic intervals” are the same as those introduced on line 9 or different therefrom. Additionally, it is unclear if the amount of lines 20-21 is based on the “determining” step of line 14 or not. For the sake of examination, the “periodic intervals” of lines 14 and 20-21 are interpreted as being the same as those introduced on line 9 and the amount on lines 20-21 is interpreted as being based on the “determining” step of line 14. Accordingly, it is suggested to amend line 14 to recite “determining how many of the periodic intervals have elapse” and to amend line 21 to recite “based on the determination of how many of the periodic intervals have elapsed”. Claims 2-8 are rejected due to their dependence on claim 1.
Re claim 5: Lines 3-4 recite “the calculated basal dosage is increased to compensate”. The phrase “the calculated basal dosage” lacks proper antecedent basis and this phrase as a whole is incomplete as it does not set forth what is being compensated for, rendering the claim indefinite. Based on the disclosure and claim 1, it appears that the “calculated” basal dosage is intended to be the “uncompensated” basal dosage; based on lines 2-3 of the claim, it appears that the compensation relates to the decrease in potency of the medicament. Therefore, this is the interpretation applied for the sake of examination. Accordingly, it is suggested to amend lines 3-4 to recite “the uncompensated basal dosage is increased to compensate for the decrease”.
Re claim 6: Line 3 recite “the calculated basal dosage”. The phrase “the calculated basal dosage” lacks proper antecedent basis. Based on the disclosure and claim 1, it appears that the “calculated” basal dosage is intended to be the “uncompensated” basal dosage. Therefore, this is the interpretation applied for the sake of examination. Accordingly, it is suggested to amend line 3 to recite “the uncompensated basal dosage”.
Re claim 9: Line 12 recites the step of “determining how many periodic intervals have elapsed” and line 20-21 recite that a magnitude of increasing/decreasing is “based on how many periodic intervals have elapsed”. It is unclear if these “periodic intervals” are the same as those introduced on line 7 or different therefrom. Additionally, it is unclear if the amount of lines 20-21 is based on the “determining” step of line 12 or not. For the sake of examination, the “periodic intervals” of lines 12 and 20-21 are interpreted as being the same as those introduced on line 7 and the amount on lines 20-21 is interpreted as being based on the “determining” step of line 12. Accordingly, it is suggested to amend line 12 to recite “determining how many of the periodic intervals have elapse” and to amend line 21 to recite “based on the determination of how many of the periodic intervals have elapsed”. Claims 10-16 are rejected due to their dependence on claim 9.
Re claim 12: Lines 1-3 recite that “the compensated basal dosage is increased when temperature of the medicament exceeds a threshold”. Claim 9 only discusses increasing or decreasing the “uncompensated” basal dosage when a threshold is exceeded, not the “compensated” basal dosage. However, claim 12 appears to introduce a new “threshold”. Therefore, it is unclear if claim 12 intends to actually require an increase of the “compensated” basal dosage based on a new “threshold” or if claim 12 intended to refer to the “uncompensated” basal dosage and the previously recited “threshold”. For the sake of examination, claim 12 is interpreted as including typographical errors and intended to refer to the “uncompensated” basal dosage and the “threshold” introduced in claim 9. Accordingly, it is suggested to amend lines 1-3 to recite “wherein the uncompensated the threshold”.
Re claim 13: Lines 1-3 recite “a magnitude which the compensated basal dosage is increased [by] depends in part on [how] much the temperature of the medicament exceeded the threshold”. Claim 9 only discusses increasing or decreasing the “uncompensated” basal dosage when a threshold is exceeded, not the “compensated” basal dosage. However, claim 13 appears to introduce a new “magnitude”. Additionally, claim 9 discusses increasing and decreasing, while claim 13 only refers to increasing. Therefore, it is unclear if claim 13 intends to actually require an increase of the “compensated” basal dosage by a new “magnitude” or if claim 13 intended to refer to the “uncompensated” basal dosage and the previously recited “magnitude”. For the sake of examination, claim 13 is interpreted as including typographical errors and intended to refer to the “uncompensated” basal dosage, the “magnitude”, and the increase and decrease of claim 9. Accordingly, it is suggested to amend lines 1-3 to recite “wherein [[a]] the magnitude which the uncompensated or decreased [by] depends in part on [how] much the temperature of the medicament exceeded the threshold”.
Re claim 14: Lines 1-4 recites “the magnitude which the compensated basal dosage is increased or decreased [by] depends at least in part on an adjustment factor that limits a magnitude of increase or decrease per periodic interval”. Claim 9 only discusses increasing or decreasing the “uncompensated” basal dosage by a magnitude, not the “compensated” basal dosage. However, claim 14 appears to introduce a new “magnitude”, “increase” and “decrease”. Therefore, it is unclear if claim 14 intends to actually require an increase or decrease of the “compensated” basal dosage by a new magnitude or if claim 14 intended to refer to the “uncompensated” basal dosage and the previously recited “magnitude”, “increase” and “decrease”. For the sake of examination, claim 14 is interpreted as including typographical errors and intended to refer to the “uncompensated” basal dosage and the “magnitude”, “increase” and “decrease” introduced in claim 9. Accordingly, it is suggested to amend lines 1-4 to recite “wherein the magnitude which the uncompensated the magnitude of the increase or the decrease per periodic interval”.
Re claim 17: Lines 14-16 recite “for at least some of the periodic intervals in the subset, calculating a difference between actual glucose levels of the user for the periodic interval and [a] predicted glucose level of the user for the periodic interval”. Based on this language, it is unclear if a “difference” is calculated for each periodic interval of if a single “difference” is calculated for the combination of multiple periodic intervals. Based on claim 17 later reciting “the calculated differences” and claims 18 and 19 reciting “the differences”, it appears that a “difference” is intended to be calculated for each periodic interval in the subset. This is the interpretation applied for the sake of examination. Accordingly, claim 17 should be amended to properly clarify this. Claims 18-20 are rejected due to their dependence on claim 17.
Re claim 17: Lines 7-9 recite that the claimed steps are intended to apply to “each selected dosage interval of at least a subset of periodic intervals in which basal dosages of insulin are delivered”, lines 10-11 recite a calculation for “a subset of periodic intervals that precede a current periodic interval”, line 14 recites “the periodic intervals in the subset”, lines 15 and 16 each recite “the periodic interval”, and lines 17-18 and 19-20 each recite “the selected periodic interval”. This combination of phrases introduces at least one “selected dosage interval”, two “subset[s] of periodic intervals” and a “current periodic interval”. It is unclear if two “subsets” were truly meant to be introduced, how the “current periodic interval” relates to the “selected dosage interval” and first introduced “subset of periodic intervals”, which of the two subsets the “periodic intervals in the subset” of line 14 is intended to refer, which of the previously recited intervals the “periodic interval” of each of lines 15 and 16 is intended to refer, and which of the previously recited periodic intervals the “selected period interval” of each of lines 17-18 and 19-20 is intended to refer. Additionally, the Specification does not make it clear as to how the claim is intended to be interpreted. Due to lack of clear guidance in the specification and the large number of possible interpretations that could be made, the scope of the claim is indefinite to a degree to which no obvious or logical interpretation can be applied. Accordingly, claims 17-20 cannot be further examined on the merits.
Re claim 20: The phrase “the determined magnitude of change in the potency of the insulin” on lines 2-3 lacks proper antecedent basis. It is unclear if claim 20 intended to introduce this “determined magnitude of change in potency” or if claim 20 intended to depend on claim 19 which already introduced this. For the sake of examination, claim 20 is interpreted as depending on claim 19 instead of claim 17. It is suggested to amend claim 20 in this manner.
Allowable Subject Matter
Claims 1-16 would be allowable if rewritten or amended in the manner suggested by the Examiner above to overcome the objections and rejections under 35 U.S.C. 112(b) set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: The subject matter of each of independent claims 1 and 9 – as amended in the 6/30/2025 filing and interpreted in the manner set forth above – could not be found nor was suggested in the prior art of record. Albertini et al. (cited in the last Office Action) remains the closest prior art of record but fails to disclose that the adjustment of the uncompensated basal dosage for the selected periodic interval (that is to compensate for the change in potency of the medicament) is “based on the determination of how many of the periodic intervals have elapsed prior to the selected periodic interval” as required by claims 1 and 9. Other relevant prior art to the current invention includes PG PUB 2004/0267321 to Boileau et al. (which discloses automatically adjusting dosages of drugs based on changes in drug efficacy to thereby ensure the optimal dosage at all times – Para 117), PG PUB 2011/0098548 to Budiman et al. (which includes a processor configured to determine a bolus amount to be delivered when the drug effectiveness has become reduced – Para ), PG PUB 2018/0336962 to Cronin et al. (which discloses a drug flow rate or dosage being modified depending on a change in the efficacy of the drug – Para 32), PG PUB 2020/0214592 to Ben-Tsur et al. (which discloses reducing dosage of a drug based on a previous increase in the efficacy of the drug – Para 228); however, none of these references alone or in combination disclose the subject matter of independent claim 1 or 9.
As set forth above, due to the degree of indefiniteness in claim 17, claims 17-20 cannot be further examined on the merits. Therefore, their allowability cannot be determined.
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.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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