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 2/12/26. As directed by the amendment: claim 15 has been amended, claims 1-10 have been cancelled, and no new claims have been added. Thus, claims 11-15 are presently pending in this application.
Election/Restrictions
Applicant’s election without traverse of Group III (claims 11-15) in the reply filed on 2/12/26 is acknowledged.
Claim Objections
Claim 14 is objected to because of the following informalities: there should be a comma after “…change in pressure” and “measure” should be “measured”. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: “involve” should be “involves”, and “Baysian” appears to be a misspelling of “Bayesian”. 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.
Claims 11-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claim(s) recite(s) steps of “estimating” and “computing”, which are equivalent to observation, judgement, or evaluation and grouped as mental processes. This judicial exception is not integrated into a practical application because there are no additional elements that link the use of the identified/claimed abstract ideas to a particular technological environment or field of use. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because “triggering” an alarm is considered insignificant extra solution activity which can be seen as simply outputting the result of the mental process claimed and can read on human activity of communicating information based on the mental process claimed.
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 11-15 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 claim 11, the limitation “estimating system compliance” is recited with no clear language linking it to the intended methodology of occlusion detection or the other steps of claim 1 revolving around occlusion detection, and it is thus unclear if this step is involved in or related to occlusion detection as claimed. Dependent claims 12-15 compound this deficiency by reciting further methodology for compliance estimation without linking that methodology to the claimed method of occlusion detection.
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.
Claim(s) 11, 13, and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wolff (US 20180311434).
Regarding claim 11, Wolff discloses a method of occlusion detection (abstract), comprising: estimating a system compliance (slope value associated with measured force; par. 0046-0055); computing a probability of a system occlusion (likelihood based on slope value range; par. 0046-0055); and triggering at least one of an occlusion alert, alarm or notification upon determining that the computed probability of a system occlusion exceeds a threshold (par. 0058-0060).
Regarding claim 13, Wolff discloses wherein the system compliance is computed as a function an expected decay in frictional force (specifically the decay portion near the end of each modelled friction curve F1-F5 in fig. 10; par. 0092-0093, 0140).
Regarding claim 14, Wolff discloses the system compliance is computed by dividing a change in pressure as measure by a force sensor, by a change in infusate volume (par. 0156; fig. 9).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wolff in view of Feldmann et al. (US 5647853).
Regarding claim 12, Wolff discloses the method as claimed except for the system compliance is computed by a measurement of a pressure reduction after cessation of a drive mechanism activation. However, Feldmann et al. teaches utilizing a pressure measurement after cessation of a drive mechanism activation for computing system compliance (measurement taken subsequent to the first pressure reading during administering and prior to administering the next dose; col. 2, ln. 38-55). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Wolff to utilize a pressure measurement after cessation of drive mechanism activation, as taught by Feldmann et al., for the purpose of providing a redundant measure for compliance in case constant pressure readings during administration fail to identify an occlusion (Feldmann et al., col. 1, ln. 42-65).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wolff in view of Allis et al. (US 20180085521).
Regarding claim 15, Wolff discloses the method as claimed, except for computing a probability of a system occlusion involve Baysian Inference. However, Allis et al. teaches utilizing Bayesian filters to compensate for random wandering pressure changes in an infusion pump (par. 0054). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Wolff to utilize Bayesian Inference as taught by Allis et al. for the purpose of avoiding false positive occlusion or system compliance readings caused by random wandering pressure changes (Allis et al., par. 0054).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Fahrer (US 20100305506) describes modeling friction decay for calibration of injector based on its lifecycle (par. 0053).
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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/NATHAN R PRICE/Primary Examiner, Art Unit 3783