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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07MAY2026, which incorporates the amendments made in the After Final Response filed 09MAR2026, has been entered.
Status of Claims
The amendments and remarks filed on 09MAR2026 have been entered and considered.
Claims 1-7, 11-22, & 26-27 are currently pending.
Claims 1, 5, 11-12, 17, & 26 have been amended.
No new matter has been added.
Claims 1-7, 11-22, & 26-27 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08MAY2026 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant's amendments filed 09MAY2026 regarding the rejections under 35 U.S.C 112(b) have been fully considered and are found to obviate the rejection. Therefore, the 112(b) rejection has been withdrawn. New grounds of rejections are provided below.
Applicant's amendments/arguments filed 09MAY2026 regarding the rejections under 35 U.S.C 101 have been fully considered and have been found to obviate the rejection. Therefore, the 101 rejections have been withdrawn.
Claim Objections
Claims 1, 11, & 26 are objected to because of the following informalities:
Regarding Claims 1 & 11:
The claims recite “wherein the wobble amount depends on a difference between the first change in patient- reported pain level compared to the second change in patient- reported pain level of the identified previously delivered dose.”. This should instead recite “wherein the wobble amount depends on the determined difference between the first change and the second change”.
Regarding Claim 26:
The claim recites “identifying, from among previously delivered doses in the patient-specific dosing database that is associated”. This should instead recite “identifying, from among previously delivered doses in the patient-specific dosing database that are associated”.
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 1-7, 11-22, & 26-27 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.
Regarding Claims 1, 11-12, & 26:
The limitation “identifying, from among previously delivered doses in the patient-specific dosing database that are associated with the greatest reduction in patient-reported pain level, a previously delivered dose having a delivery time of day that is closest to the first time of day; determining a first change in patient-reported pain level associated with the new dose compared to other previously delivered doses in the patient-specific dosing database; identifying a second change in patient-reported pain level associated with the identified previously delivered dose compared to other previously delivered doses in the patient-specific dosing database; determining a difference between the first change in patient-reported pain level associated with the new dose and the second change in patient-reported pain level associated with the identified previously delivered dose; and adjusting a wobble amount…”, for claims 1 & 11; and limitation “determining a first change in patient-reported pain level associated with the new dose compared to other previously delivered doses in the patient-specific dosing database; identifying a second change in patient-reported pain level associated with the identified previously delivered dose compared to other previously delivered doses in the patient-specific dosing database…” for claims 12 & 26. It is unclear whether the “first change” and “second change” are each a pre-and-post-dose pain for a single dose, or instead a comparative ranking relative to other doses in the database. Applicant should clarify the calculation for each “change” and separately recite any comparison or ranking against other stored doses such as found in the specification in paragraphs [0028]-[0033], [0043], [0073]-[0077] provides relevant support for these limitations.
Claims 2-7 & 27 are further rejected for depending upon the rejected claim 1.
Claims 13-22 are further rejected for depending upon the rejected claim 12.
Regarding Claim 6:
The claim recites “the set of treatment dose parameters for the new subsequent dose” In lines 2-3 lacks clear antecedent basis with the limitation of “new dose” recited in claim 1 and makes term “new subsequent dose” unclear. It is recommended to change the “new subsequent dose” to ”subsequent new dose”.
Regarding Claim 12:
The claim recites “wherein gathering the set of dose parameters delivering the one or more new doses comprises, for each new dose that is delivered:” is unclear since there is omitted connector/punctuation between “gathering” and “delivering” steps. It is recommended to change the limitation to “wherein gathering the set of dose parameters and delivering the one or more new doses comprise” as seen in the specification in paragraphs [0073]-[0077].
Claims 13-22 are further rejected for depending upon the rejected claim 12.
Regarding Claim 20:
The claim recites “further accounting for any adjustments made to the dose parameters made during delivery to the dose selector for entry into the patient-specific dosing database” is unclear whether the adjustments are made “to the dose selector,” or instead provided to the dose selector for database entry. It is recommended to change this limitation to “further comprising providing to the dose selector, for entry into the patient-specific dosing database, any adjustments made to the dose parameters during delivery” as seen consistent with [0028], [0075], [0077] of the specification.
Allowable Subject Matter
Claims 1-7, 11-22, & 26-27 do not currently have any prior art rejections applied. However, the claims do not stand in condition for allowance due to the pending claim objections & 35 USC 112(b) rejections.
The following is a statement of reasons for overcoming the art of record:
In view of the persuasive arguments filed in the Remarks, none of the prior art of record
explicitly discloses or teaches all of the claimed elements of Claims 1, 11-12, & 26 particularly as
currently written. After further search and consideration, it has been determined that the prior art and
possible combination of relevant references fails to arrive at the claimed invention, particularly the "identifying a previously delivered dose in the patient-specific dosing database that is associated with the greatest reduction in patient-reported pain level a previously delivered dose having a delivery time of day and that is delivered at a second time of day that is closest to the first time of day. ". The prior art includes does not provide relative times of day and
relative reduction in pain between those times of day as claimed by the instant application. Conclusion
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/MEGAN T FEDORKY/Examiner, Art Unit 3796
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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