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 .
Response to Amendment
This office action is responsive to the amendment filed on 1/23/26. As directed by the amendment: claims 1, 5, and 7 have been amended, claims 16-20 have been cancelled, and no new claims have been added. Thus, claims 1-15 are presently pending in this application, claims 8-15 being withdrawn from consideration.
The amendments to claims 5 and 7 are sufficient to overcome the 35 U.S.C. 112(b) rejections of those claims from the prior office action.
The rejections under 35 U.S.C. 101 are withdrawn in light of the amendments made to the claims and related arguments presented on pg. 5-8 of the Remarks.
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 3 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 3, it is unclear how a maximum delivery limit, which appears to be a value from parent claim 1, is further limited by the recitation of being “constrained between a lower limit and an upper limit”. It further unclear if this limitation from claim 3 is broadening the maximum delivery limit, which would be improper under 35 U.S.C. 112(d). For the purposes of examination, a maximum delivery limit in the form of either a calculated value or range will be interpreted to inherently be “constrained” relative to values above/below the calculated limit or range.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 appears to only repeat a limitation found in claim 1 without adding any further limitation and in potentially broader language. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(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.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Keenan et al. (US 20140066892).
Regarding claim 1, Keenan et al. discloses a method performed by a medicament delivery system (abstract) comprising: executing a basal dosing algorithm with a controller of the medicament delivery system (abstract), wherein each cycle of the algorithm comprises: receiving a blood glucose reading (par. 0193-0209) from a glucose sensor (par. 0011); determining a required basal dose based on the received blood glucose reading (par. 0193-0209); adjusting a maximum delivery limit (par. 0376-0377; 0493-0495); and determining a basal dose to be delivered, the basal dose comprising the lesser of the required basal dose and a dose limited by the maximum delivery limit (par. 0376-0377; 0493-0495); and delivering the basal dose as one or more micro-boluses via a medicament pump of the medicament delivery system (par. 0208 – amount of insulin per discrete time interval).
Regarding claim 2, Keenan et al. discloses delivering the basal dose as one or more micro-boluses (par. 0208 – amount of insulin per discrete time interval).
Regarding claim 3, as best understood, Keenan et al. discloses the maximum delivery limit is constrained between a lower limit and an upper limit (the result of the limit calculation will inherently be constrained by the calculation relative to values that fall above or below the result of the calculation).
Regarding claim 4, Keenan et al. discloses adjusting the maximum delivery limit comprises: calculating a percentage of time during a past predetermined time period that delivery of insulin had been limited by the maximum delivery limit (“end of the night period”, par. 0494); and adjusting the maximum delivery limit based on the calculated percentage (calculation of the maximum delivery limit is adjusted based on information derived from to this period; par. 0493-0495).
Regarding claim 5, Keenan et al. discloses adjusting the maximum delivery limit comprises multiplying a factor that is is a function of the calculated percentage and a current maximum delivery limit by a basal rate (the maximum delivery limit will inherently be some product of some factor and some basal rate; par. 0493-0495 describe relationships between the calculated percentage and maximum delivery limit).
Regarding claim 6, Keenan et al. discloses the percentage of time during a past predetermined time period that delivery of insulin has been limited by the maximum delivery limit is calculated as a percentage of cycles of the basal dosing algorithm (percentage of cycles constrained by the end of the night period).
Regarding claim 7, Keenan et al. discloses the maximum delivery limit is adjusted upward when the percentage of time is above a threshold and the maximum delivery limit is adjusted downward when the percentage of time is below the threshold (par. 0493-0495).
Claim(s) 1-7 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Graham et al. (US 20220023536).
Regarding claim 1, Graham et al. discloses a method performed by a medicament delivery system (system 200, fig. 2; par. 0053) comprising: executing a basal dosing algorithm with a controller of the medicament delivery system, wherein each cycle of the algorithm comprises: receiving a blood glucose reading from a glucose sensor; determining a required basal dose based on the received blood glucose reading; adjusting a maximum delivery limit; and determining a basal dose to be delivered, the basal dose comprising the lesser of the required basal dose and a dose limited by the maximum delivery limit (par. 0053 describes the entire methodology of claim 1 thus far); and delivering the basal dose as one or more micro-boluses via a medicament pump of the medicament delivery system (par. 0019 describes subdividing basal dose into segments).
Regarding claim 2, Graham et al. discloses delivering the basal dose as one or more micro-boluses (par. 0019 describes subdividing basal dose into segments).
Regarding claim 3, as best understood, Graham et al. discloses the maximum delivery limit is constrained between a lower limit and an upper limit (the result of the limit calculation will inherently be constrained by the calculation relative to values that fall above or below the result of the calculation).
Regarding claim 4, Graham et al. discloses adjusting the maximum delivery limit comprises: calculating a percentage of time during a past predetermined time period that delivery of insulin had been limited by the maximum delivery limit; and adjusting the maximum delivery limit based on the calculated percentage (par. 0053).
Regarding claim 5, Graham et al. discloses adjusting the maximum delivery limit comprises multiplying a factor that is is a function of the calculated percentage and a current maximum delivery limit by a basal rate (par. 0053).
Regarding claim 6, Graham et al. discloses the percentage of time during a past predetermined time period that delivery of insulin has been limited by the maximum delivery limit is calculated as a percentage of cycles of the basal dosing algorithm (par. 0053).
Regarding claim 7, as best understood, Graham et al. discloses the maximum delivery limit is adjusted upward when the percentage of time is above a threshold and the maximum delivery limit is adjusted downward when the percentage of time is below the threshold (par. 0053).
Response to Arguments
Applicant's arguments filed 1/23/26 have been fully considered but they are not persuasive.
Regarding the arguments on pg. 8-9 of the Remarks directed to the 112(b) rejection of claim 3, Examiner maintains that it is not clear from the claim as written that the claimed upper and lower limits are limits are tied to the step of adjusting a maximum delivery limit in claim 1. The claim, as written, only appears to recite that “the maximum delivery limit” is constrained between these limits, which encompasses the indefiniteness identified in the previous action.
Applicant variously argues, on pg. 9-13 of the Remarks, that both Keenan et al. and Graham et al. fail to disclose the claimed invention, supporting this argument by citing various factors which do not appear to be explicitly claimed. For example, terms such as “cycle” and “algorithm”, contrary to Applicant’s arguments, are being interpreted according to their broadest reasonable interpretation, a cycle being interpreted as a repeatable series of events, and an algorithm being a process/set of rules/set of instructions/etc. Examiner maintains that both Keenan et al. and Graham et al. disclose the limitations presented as claimed.
Applicant’s arguments, on pg. 5-8 of the Remarks, directed the rejections under 35 U.S.C. 101 form the previous action, in light of the amendments to the claims, are found persuasive, and those rejections are withdrawn.
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 NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 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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/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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