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 7/2/26. As directed by the amendment: claims 11, 14, and 15 have 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.
The claim amendments are sufficient to overcome the claim objections from the prior action.
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 “determining” and “comparing”, 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. Notably, the amended recitation of an infusion pump and its components in the preamble amount to describing the source of the object/phenomenon to which the claimed mental processes can be directed as observation, judgement, or evaluation. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because “triggering” an occlusion alert 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 12-15 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 claims 12-14, “the system compliance” lacks antecedent basis in the claims, and it is unclear if “the system compliance” is the same as or different from “a material compliance of the system” now recited in amended claim 11. The claims further lack any clear link between system compliance and the claimed methodology in claim 11 such that they can be clearly interpreted as part of the method.
Regarding claim 15, it is unclear how computing a probability of a system occlusion relates to methodology in claim 1. In other words, as worded, the claim appears to recite a relative input for computing the claimed probability without incorporating the probability determination/measurement into the method as a whole.
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) for an infusion pump (fig. 1) having a plunger 21 driven by a drive mechanism 12 configured to be advanced within a cartridge 2 containing an infusate so as to expel the infusate from the cartridge (par. 0089), and a force sensor configured to sense a force exerted by the drive mechanism on the plunger (par. 0091), the method comprising: determining an estimated force based on an expected decay in frictional force between the plunger and the cartridge after the plunger has stopped advancing (par. 0046-0055 describing estimated forces for comparison to measured forces; fig. 4 and par. 0112 describing and illustrating force profile covering the entire procedure, and starting with par. 0115 the process of modelling the expected frictional force); comparing the estimated force to the actual force sensed by the force sensor (par. 0046-0055); and triggering an occlusion alert if a deviation between the estimated force and the actual force exceeds a threshold (par. 0058-0060), wherein the estimated force is further based on a distance moved by the plunger (see at least par. 01290-0131) and a material compliance of the system (par. 0055-0056).
Regarding claim 13, as best understood, 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, as best understood, 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, as best understood, 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, as best understood, Wolff discloses the method as claimed, except for computing a probability of a system occlusion involves Bayesian 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).
Response to Arguments
Applicant's arguments filed 7/2/26 have been fully considered but they are not persuasive. Applicant argues that the newly amended limitations in claim 11 both overcome the rejection under 101 and are not disclosed by Wolff. In response, Examiner has updated the rejections of claim 11 above to address the newly amended claim limitations.
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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