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 .
Status of Claims
This office action is responsive to the application filed 23 August 2023.
In a provisional election/restriction requirement, claims 3-21 were elected.
Claims 1-2 are withdrawn.
Claims 3-21 are presently pending in this application.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1 and 2, drawn to a method of controlling quantities of insulin dispensed, classified in G16H40/63.
II. Claims 3-21, drawn to a drug delivery system, classified in A61M2005/14208.
The inventions are independent or distinct, each from the other because:
Inventions I and II are directed to an unrelated product and process. Product and process inventions are unrelated if it can be shown that the product cannot be used in, or made by, the process. See MPEP § 802.01 and § 806.06. In the instant case, invention II cannot be made or used by the process of invention I. Invention I is drawn to adjustment of delivery parameters via a Kraft test, which is not present nor required of invention II.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions have acquired a separate status in the art in view of their different classification
The inventions have acquired a separate status in the art due to their recognized divergent subject matter
The inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries)
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Matthew Fagan on 27 January 2026, a provisional election was made without traverse to prosecute the invention of invention II, claims 3-21. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1 and 2 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because of the following reference characters:
"103" and "108" have both been used to designate an analyte sensor (para. 0019).
"106" and "107" have both been used to designate an accessory device (para. 0036).
"158" and "160" have both been used to designate a user app (para. 0055-0056).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 3-21 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.
Claims 3 and 15 recite the limitation “the insulin administered” in lines 7 and 11 of claims 3 and 15 respectively. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, examiner interprets “the insulin administered” to mean "insulin administered”.
Claims 11 and 19 recite the limitation "the current insulin response test" in lines 4 and 3 of claims 11 and 19 respectively. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, examiner interprets “the current insulin response test” to mean "an insulin response test".
Claim 13 recites the limitation “the final insulin response factor” in line 4 of the claim. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, examiner interprets “the final insulin response factor” to mean "a final insulin response factor".
Claims 19 and 20 recite the limitation “the insulin response factor” in line 2 and 3 of the claims respectively. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, examiner interprets “the insulin response factor” to mean "an insulin response factor".
All other claims are rejected as they depend from independent claims 3 and 15.
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.
Claims 3, 4, 6, 9, 10, 14-17, and 21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yodfat et al. (US Patent Publication No. 20100286601 A1), hereinafter Yodfat.
Regarding claim 3, Yodfat teaches a method (Yodfat: Fig. 9), in an automatic drug delivery system (Fig. 5a, device 1000), for directing a user to administer a self-guided insulin resistance test comprising: advising the user to fast for a predetermined fasting time (Fig. 9, in block 60, user is advised to fast for 5 hours; para. 0163); advising the user to ingest a predetermined quantity of fast-acting carbohydrates (Fig. 9, block 61, user can be asked to consume a specific amount of carbohydrates like glucose; para. 0095 and 0099); determining, for a predetermined post-prandial period after ingestion of the fast-acting carbohydrates whether an insulin administered (Fig. 9, block 61, correction bolus can be administered; para. 0143) during the post-prandial period is sufficient to lower blood glucose levels of the user to a baseline value (Fig. 9, block 60, user’s blood glucose level CBG is measured and verified if in the target range TBG; para. 0155); and when the insulin administered during the post-prandial period (61) is insufficient (Fig. 9, block 60a, if CBG is not in target zone; para. 0169), adjusting parameters of a medication delivery algorithm to correct for insulin resistance (Fig. 9, the correction bolus is adjusted based on insulin sensitivity; para 0144 and para. 0169) of the user. When the prior art device is the same as a device described in the specification for carrying out or being made by the claimed method, it can be assumed the device will obviously perform or be made by the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). MPEP 2112.02
Regarding claim 4, Yodfat teaches the method above, wherein advising the user to fast for the predetermined fasting time (60) comprises providing an instruction to the user in a user interface (Fig. 7b, display device 3030) of the automatic drug delivery system (1000) advising of the length of the fasting time (60, para. 0163).
Regarding claim 6, Yodfat teaches the method above, wherein advising the user to ingest a predetermined quantity of fast-acting carbohydrates (61) comprises providing an instruction to the user in the user interface (3030) of the automatic drug delivery system (1000), the instruction including the desired quantity of fast-acting carbohydrates to be ingested (the amount of carbohydrates to consume is calculated and the user is advised; para. 0152 and 0155).
Regarding claim 9, Yodfat teaches the method above, further comprising: providing an instruction in a user interface (160) of the automatic drug delivery system (1000) instructing the user not to eat during the post-prandial period (Fig. 9, after ingesting carbohydrates at block 61, user is advised to fast for at least 5 hours; para. 0163).
Regarding claim 10, Yodfat teaches the method above, further comprising: determining, during the post-prandial period, an insulin response factor (Fig. 9, after ingesting carbohydrates at block 61, the insulin sensitivity, or IS, is determined; para. 0007 and 0163).
Regarding claim 14, Yodfat teaches the method above, wherein adjusting parameters of the medication delivery algorithm (recommended food adjustment is based on glucose concentration change; para. 0032 and claim 116) comprises: adjusting a recommended glucose target for the user (para. 0032 and claim 116).
Regarding claim 15, Yodfat teaches a system (1000) comprising: a drug delivery device (Fig. 5a, insulin infusion unit 1010); a blood glucose sensor (Fig. 20a, glucose measurement unit 90) in communication with the drug delivery device (Fig. 20a, unit 90 is part of remote control unit 1008 which communicates with the unit 1010; para. 0135); a user device (Fig. 20a, remote control unit 1008) in communication with the drug delivery device (para. 0135); and software executing on the user device or on the drug delivery device (Fig. 9, the algorithm of Fig. 9 can be carried out via software in the unit 1008 via processor 3010; para. 0138 and 0207) which causes the system to: advise the user to fast for a predetermined fasting time (Fig. 9, in block 60, user is advised to fast for 5 hours; para. 0163); advise the user to ingest a predetermined quantity of fast-acting carbohydrates (Fig. 9, block 61, user can be asked to consume a specific amount of carbohydrates like glucose; para. 0095 and 0099); determine, for a predetermined post-prandial period after ingestion of the fast-acting carbohydrates whether an insulin administered (Fig. 9, block 61, correction bolus can be administered; para. 0143) during the post-prandial period is sufficient to lower blood glucose levels of the user to a baseline value (Fig. 9, block 60, user’s blood glucose level CBG is measured and verified if in the target range TBG; para. 0155); and when the insulin administered during the post-prandial period (61) is insufficient (Fig. 9, block 60a, if CBG is not in target zone; para. 0169), adjust parameters of a medication delivery algorithm to correct for insulin resistance (Fig. 9, the correction bolus is adjusted based on insulin sensitivity; para 0144 and para. 0169) of the user.
Regarding claim 16, Yodfat teaches the device above, the software causing the system to: provide an instruction to the user in a user interface (Fig. 7b, display device 3030) of the user device (1008) advising of the length of the fasting time (60, para. 0163).
Regarding claim 17, Yodfat teaches the device above, the software further causing the system to: provide an instruction to the user in the user interface (3030) of the user device (1008), the instruction including the desired quantity of fast-acting carbohydrates to be ingested (the amount of carbohydrates to consume is calculated and the user is advised; para. 0152 and 0155).
Regarding claim 21, Yodfat teaches the device above, the software further causing the system to: adjust a recommended glucose target for the user (para. 0032 and claim 116).
Claim Rejections - 35 USC § 103
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Yodfat.
Regarding claim 5, Yodfat teaches the method above.
Yodfat does not expressly disclose the predetermined fasting time is 10 hours. However, Yodfat discloses a fasting time of at least 5 hours (Yodfat: para. 0143), which includes a fasting time of 10 hours.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the fasting time to be 10 hours as taught by Yodfat in order to eliminate the influence of residual insulin (para. 0163). Furthermore, applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with other fasting times. Absent a teaching as to criticality of the fasting time of 10 hours, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Claim 7, 8, 11-13, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Yodfat in view of Sjolund et al. (US Patent No. 11197964 B2), hereinafter Sjolund.
Regarding claim 7, Yodfat teaches the method above,
Yodfat does not expressly disclose that the instruction further comprises providing suggestions of foods for the user to ingest comprising the desired quantity of fast- acting carbohydrates.
Sjolund teaches an instruction comprises providing suggestions of foods for the user to ingest comprising the desired quantity of fast-acting carbohydrates (Sjolund: Fig. 23, user interface can suggest fast-acting carb meals based on desired quantity; col 33, ln 12-27).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Yodfat such that the instruction further comprises providing suggestions of foods for the user to ingest comprising the desired quantity of fast- acting carbohydrates as taught by Sjolund in order to inform the user on what carbohydrates to consume as well as the estimated amount of carbs that the meal comprises (Sjolund: col 33, ln 12-27).
Regarding claim 8, Yodfat teaches the method above.
Yodfat does not expressly disclose that the instruction further comprises a field allowing the user to enter the exact quantity of fast-acting carbohydrates that were ingested.
Sjolund teaches an instruction comprises a field allowing the user to enter the exact quantity of fast-acting carbohydrates that were ingested (user can select a meal ingested; col 20, ln 27-53).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Yodfat such that the instruction further comprises a field allowing the user to enter the exact quantity of fast-acting carbohydrates that were ingested as taught by Sjolund in order to provide updated dosage recommendations (Sjolund: col 20, ln 27-53).
Regarding claim 11, Yodfat teaches the method above.
Yodfat does not expressly disclose determining a final insulin response factor comprises: aggregating an insulin response factor calculated during the post-prandial period of the current insulin response test with a final insulin response factor from a previous insulin response test.
Sjolund teaches determining a final insulin response factor (Sjolund: algorithms can update the insulin sensitivity factor based on detected patterns; col 34, ln 27-67 and col 57, ln 64-67) comprises: aggregating the insulin response factor (insulin sensitivity factor may be mathematically inferred between user’s daily dosage of insulin; col 33, ln 53-55) calculated during the post-prandial period (system 3420 can collect post-prandial data, such insulin sensitivity factor; col 4, ln 53 – col 5, ln 5 and col 33, ln 53-55) of an insulin response test (col 33, ln 53-55) with a final insulin response factor from a previous insulin response test (algorithms can update the insulin sensitivity factor based on detected patterns; col 34, ln 27-67 and col 57, ln 64-67).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Yodfat such that determining a final insulin response factor comprises: aggregating the insulin response factor calculated during the post-prandial period of the current insulin response test with a final insulin response factor from a previous insulin response test as taught by Sjolund in order to determine recommended therapy setting changes and to improve glycemic outcomes (Sjolund: col 34, ln 27-67).
Regarding claim 12, Yodfat in view of Sjolund discloses the method above.
Yodfat does not expressly disclose that each cycle of the medication delivery algorithm is 5 minutes in duration.
Sjolund teaches each cycle of a medication delivery algorithm is 5 minutes in duration (blood glucose data is received every 5 minutes; col 12, ln 20-34).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Yodfat such that each cycle of the medication delivery algorithm is 5 minutes in duration as taught by Sjolund in order to provide updates to therapy parameters if necessary (col 15, ln 13-30).
Regarding claim 13, Yodfat teaches the method above.
Yodfat does not expressly disclose that adjusting parameters of the medication delivery algorithm to correct for insulin resistance of the user comprises: adjusting a total daily insulin input parameter of the medication delivery algorithm by the final insulin response factor.
Sjolund teaches adjusting parameters of the medication delivery algorithm (Sjolund: adjust insulin delivery parameters; col 4, ln 53 – col 5, ln 5) to correct for insulin resistance (ISF) of the user comprises: adjusting a total daily insulin input parameter (total daily dose of basal insulin; col 4, ln 53 – col 5, ln 5) of the medication delivery algorithm (col 4, ln 53 – col 5, ln 5) by the final insulin response factor (algorithms can update the insulin sensitivity factor based on detected patterns; col 34, ln 27-67 and col 57, ln 64-67).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Yodfat such that adjusting parameters of the medication delivery algorithm to correct for insulin resistance of the user comprises: adjusting a total daily insulin input parameter of the medication delivery algorithm by the final insulin response factor as taught by Sjolund in order to provide updates to therapy parameters if necessary (col 15, ln 13-30).
Regarding claim 18, Yodfat teaches the device above.
Yodfat does not expressly disclose the software causing the system to: provide suggestions of foods for the user to ingest comprising the desired quantity of fast-acting carbohydrates.
Sjolund teaches a software causing a system (Sjolund: col 11, ln 36-54) to: provide suggestions of foods for the user to ingest comprising the desired quantity of fast-acting carbohydrates (Sjolund: Fig. 23, user interface can suggest fast-acting carb meals based on desired quantity; col 33, ln 12-27).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Yodfat such that the instruction further comprises providing suggestions of foods for the user to ingest comprising the desired quantity of fast- acting carbohydrates as taught by Sjolund in order to inform the user on what carbohydrates to consume as well as the estimated amount of carbs that the meal comprises (Sjolund: col 33, ln 12-27).
Regarding claim 19, Yodfat teaches the device above.
Yodfat does not expressly disclose the software further causing the system to: aggregate the insulin response factor calculated during the post-prandial period of the current insulin response test with a final insulin response factor from a previous insulin response test.
Sjolund teaches a software causing a system (Sjolund: col 11, ln 36-54) to: aggregate an insulin response factor (insulin sensitivity factor may be mathematically inferred between user’s daily dosage of insulin; col 33, ln 53-55) calculated during the post-prandial period (system 3420 can collect post-prandial data, such insulin sensitivity factor; col 4, ln 53 – col 5, ln 5 and col 33, ln 53-55) of an insulin response test (col 33, ln 53-55) with a final insulin response factor from a previous insulin response test (algorithms can update the insulin sensitivity factor based on detected patterns; col 34, ln 27-67 and col 57, ln 64-67).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Yodfat such that the software further causing the system to: aggregate the insulin response factor calculated during the post-prandial period of the current insulin response test with a final insulin response factor from a previous insulin response test as taught by Sjolund in order to determine recommended therapy setting changes and to improve glycemic outcomes (Sjolund: col 34, ln 27-67).
Regarding claim 20, Yodfat teaches the device above.
Yodfat does not expressly disclose the software further causing the system to: adjust a total daily insulin input parameter of the medication delivery algorithm by the final insulin response factor.
Sjolund teaches software causing a system (Sjolund: col 11, ln 36-54) to: adjust a total daily insulin input parameter (total daily dose of basal insulin; col 4, ln 53 – col 5, ln 5) of the medication delivery algorithm (col 4, ln 53 – col 5, ln 5) by the final insulin response factor (algorithms can update the insulin sensitivity factor based on detected patterns; col 34, ln 27-67 and col 57, ln 64-67).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Yodfat such that the software further causing the system to: adjust a total daily insulin input parameter of the medication delivery algorithm by the final insulin response factor as taught by Sjolund in order to provide updates to therapy parameters if necessary (col 15, ln 13-30).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEI GONZALEZ whose telephone number is (703)756-5908. The examiner can normally be reached 7:30am - 4:00pm (CT).
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/LEI GONZALEZ/ Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783