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
The Amendment filed 09 Jan 2026 has been entered. Claims 1-3, 5-9, 11-15, 17-21 and 24 are pending in the application with claims 4, 10, 16 and 22-23 canceled. Claims 1, 7, 12-13 and 18-19 are currently amended. Applicant’s amendment to the Claims have overcome most, but not every, objection and 35 U.S.C. 112 rejection previously set forth in the Non-Final Office Action mailed 11 Sep 2025. The remaining issue is restated below.
Response to Arguments
Applicant's arguments filed 09 Jan 2026 have been fully considered but they are not persuasive. Regarding the 35 U.S.C. 101 rejection applicant argues the claims are integrated into a practical application and thus should not be rejected under 35 U.S.C. 101 (Pg. 9-10). Specifically, applicant argues the context of the claims is tied to the real-world application of predicting inhale dose in the context of inhaler-based drug delivery.
While acknowledging the intended application of the claimed invention it is respectfully submitted that applicant may not be accounting for the breadth of the present claim language. For example, the preamble of claim 1 recites “A method for estimating an inhale dose when a drug is delivered to a person using an inhaler”. While that preamble provides context for the steps of the claim it does not, by example, use the inhaler to perform the estimating, imply any exact timing during which the estimating must take place, or positively recite drug delivery with the inhaler.
The three steps in the body of claim 1 are two obtaining steps and one estimating step. The term “obtaining” only implies a gathering of information. It is noted that the claim has no concern for how the two parameters are obtained. For example, is a sensor used? Are the parameters pre-stored in a memory? Can the parameters be merely visually ascertained? Can the inhaler be tested in the hours after usage to obtain the necessary parameters? Thus, the obtaining steps of the claim still merely amount to pre-solution data collection which is not meaningfully enough linked to the intended technological improvement (e.g. MPEP 2106.05(g)).
Further, the estimating step of the claim recites a particular equation which must be performed with values not explicitly accounted for by the claim. There are six separate variables in the equation of the estimating step and none of those six variables are expressly sensed, measured, collected, etc. by the claim. The estimating step can thus only be considered the performance of a mathematical equation, which could be mentally performed, which fails to meaningfully be drawn to a particular technological improvement since the claim has no concern for how the supposedly essential variables of the claimed equation are obtained or the timing in which the estimating must take place.
The same responses also apply to independent claims 7, 13 and 19.
Applicant’s citation to Diamond v. Diehr fails to appreciate the Supreme Court’s view in that case that the claims should not be rejected under 35 U.S.C. 101 because of the meaningful and concrete steps further performed beyond the abstract idea (see discussion in MPEP 2106.05(e)). The present claims with their only steps being “obtaining” and “estimating” are still clearly only drawn to abstract ideas of mathematical formula and mental process.
Applicant is suggested to specify in the claims such possibilities as: 1) how the essential variables of the claim are sensed, measured, collected, etc. for inclusion in the claimed formula, 2) to positively recite a delivering of the drug to the person with the inhaler, 3) to recite how the estimated predicted inhale dose is used to provide feedback to improve inhaler usage, etc. Such amendments would likely help to establish the context in the claims of the inhaler-based drug delivery applicant is intending.
Claim Objections
Claim(s 19 is/are objected to because of the following informalities:
Claim 19, Ln. 5-6 recites “a breath pattern” which should read “the breath pattern” following after Ln. 3. It is noted that the present amendment incorrectly presents the edit in Ln. 5 of the claim as “[[the]] a” when the prior claim set had read “a” and not “the” at that location.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim(s) 1-3, 5-9, 11-15, 17-21 and 24 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 recites the steps of obtaining two parameters and then performing an estimation based on those two parameters. Further, the estimation step recites a particular formula which uses six variables, but for which none of those six variables are directly linked to the obtaining steps of the claim. The steps in combination merely amount to either the forming of a mathematical relationship (see MPEP 2164.04(a)(2)(I)) or steps reasonably performable as a mental process (see MPEP 2164.04(a)(2)(III)). This judicial exception is not integrated into a practical application because the resulting es. The obtaining steps of the claim merely amount to pre-solution data collection which is not meaningfully enough linked to the intended technological improvement at least because the claim has no concern for how the two parameters are obtained (e.g. MPEP 2106.05(g)). The estimating step can only be considered the performance of a mathematical equation, which could be mentally performed, which fails to meaningfully be drawn to a particular technological improvement since the claim has no concern for how the supposedly essential variables of the claimed equation are obtained or the timing in which the estimating must take place. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because no structure is positively recited by the method of claim 1. Each of claims 2-3 and 5-6 only further recite what parameter is being obtained by claim 1 and thus also fail to amount to significantly more than the judicial exception.
Claim 7 recites an apparatus performing the same steps as the method of claim 1. The steps, again, in combination merely amount to either the forming of a mathematical relationship (see MPEP 2164.04(a)(2)(I)) or steps reasonably performable as a mental process (see MPEP 2164.04(a)(2)(III)). This judicial exception is not integrated into a practical application because the resulting es. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only structure recited by claim 7 are a processor and a memory. However, those electronic structures are only generically recited and fail to perform any functionality in the claim which could not be reasonably expected to be able to be performed by a human mind (see MPEP 2164.04(a)(2)(III)(C-D)). Each of claims 8-9 and 11-12 only further recite what parameter is being obtained by claim 7 and thus also fail to amount to significantly more than the judicial exception.
Claim 13 recites a non-transitory storage medium with instructions stored capable of performing the same steps as the method of claim 1. The steps, again, in combination merely amount to either the forming of a mathematical relationship (see MPEP 2164.04(a)(2)(I)) or steps reasonably performing as a mental process (see MPEP 2164.04(a)(2)(III)). This judicial exception is not integrated into a practical application because the resulting es. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only structure recited by claim 13 is a non-transitory storage medium. However, that electronic structure is only generically recited and fails to perform any functionality in the claim which could not be reasonably expected to be able to be performed by a human mind (see MPEP 2164.04(a)(2)(III)(C-D)). Each of claims 14-15 and 17-18 only further recite what parameter is being obtained by claim 19 and thus also fail to amount to significantly more than the judicial exception.
Claim 19 recites a method comprising similar steps to the method of claim 1. The steps, again, in combination merely amount to either the forming of a mathematical relationship (see MPEP 2164.04(a)(2)(I)) or steps reasonably performing as a mental process (see MPEP 2164.04(a)(2)(III)). It is noted that neither of the “inputting” nor the “measuring” steps require any structure and are thus particularly broad in scope. This judicial exception is not integrated into a practical application because the resulting es. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only structure possibly positively recited by claim 19 is an inhaler. However, the inhaler is only generically recited and is generally incidental to the steps of the claim. Each of claims 20-21 and 24 only further recite what parameter is being obtained by claim 19 and thus also fail to amount to significantly more than the judicial exception.
Allowable Subject Matter
Claim(s) 1-3, 5-9, 11-15, 17-21 and 24 are allowed over the prior art. The claims are solely rejected based upon the above 35 U.S.C. 101 rejection.
The following is a statement of reasons for the indication of allowable subject matter: Regarding claim 1, the claim is allowed for having been amended to include the limitations of former claim 4, which was indicated as allowable subject matter in the preceding Office action. Regarding claim 7, the claim is allowed for having been amended to include the limitations of former claim 10, which was indicated as allowable subject matter in the preceding Office action. Regarding claim 13, the claim is allowed for having been amended to include the limitations of former claim 16, which was indicated as allowable subject matter in the preceding Office action. Regarding claim 19, the claim is allowed for having been amended to include the limitations of former claim 22, which was indicated as allowable subject matter in the preceding Office action.
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 JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785