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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “AI unit” in claim 1, “alarm unit” in claim 5, and “correlation analysis unit” in claim 6. These limitations are so interpreted because they include a nonce term, “unit”, recite a function, and do not recite any particular structure.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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(s) 1-3, 5-6 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pre-Grant Publication 2019/0117891 to Carothers et al. (Carothers hereinafter) in view of US Pre-Grant Publication 2018/0001009 to Crawford et al. (Crawford).
Regarding claim 1, Carothers teaches an infusion system (10) comprising an infusion pump (120) configured to convey a fluid (from 110) through a fluid conduit (111, 121), a sensor (130) for producing force data, and an AI unit (161, 162, see paragraph 30) configured to calculate a number of target variables (upstream and downstream occlusion determinations) depending on the sensor data using a statistical model as a basis (paragraph 30) which was trained on historical training data. Carothers further teaches determination of the location of occlusion (upstream or downstream according to the signatures of such events discussed in paragraph 47), but does not teach determination of correlation with distance. Crawford teaches another blockage detection system generally, and particularly teaches that distance to an occlusion may be determined (paragraph 139) from pressure and other data. Crawford teaches that this allows for identification of particular occluding equipment (paragraph 139) One of ordinary skill in the art would have found it obvious before the effective filing date of the application to identify the distance from the sensor to the occlusion as taught by Crawford in the system of Carothers by the use of pressure data in order to identify malfunctioning equipment.
Regarding claim 2, Carothers teaches a force sensor (130).
Regarding claim 3, Carothers teaches determining absolute pressure (paragraph 25, “estimated fluid pressure”).
Regarding claim 5, Carothers teaches an alarm unit (170) configured to verify whether an alarm condition (occlusion) is satisfied based on the target variables and to produce an alarm (paragraph 29). Some elements of the verification may be performed by the processor and memory.
Regarding claim 6, Carothers teaches a correlation analysis unit (608) configured to calculate weight factors (regression parameters, see paragraph 74) based on the sensor data (from 606) and the target variables (at 614), and the alarm unit is configured to verify the alarm condition based on those factors (at 616 and 618).
Regarding claim 8, Carothers teaches that the sensor (130) is configured to produce force data generally, including from a resultant force produced on a piston of a syringe piston (for instance, if such a syringe were connected upstream of the sensor, the hydraulic force produced thereby would be registered by the sensor).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carothers in view of Crawford and US Pre-Grant Publication 2021/0121623 to Ujita et al. (Ujita hereinafter).
Regarding claim 4, Carothers teaches the limitations of claim 1 as discussed above, but does not teach determining training data from multiple pumps. Ujita teaches determining the model, and thereby the target variables based on data from multiple pumps (see Fig. 7). Ujita further teaches that this allows improved abnormality recognition in AI systems. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use data from a second pump to determine training data and thereby improve abnormality recognition.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carothers in view of Crawford and US Pre-Grant Publication 2021/0330881 to Paiam et al. (Paiam).
Regarding claim 7, Carothers teaches the limitations of claim 5 from which claim 7 depends, but does not teach stopping the infusion pump in response to an alarm. Paiam teaches another occlusion detection device generally, and particularly teaches that in the event of an occlusion, the pump is stopped (see paragraphs 108 and 113). Those of skill in the art will appreciate that such stoppage may prevent damage or incorrect infusion amounts. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to stop the pump of Carothers in the event of an occlusion alarm in order to prevent damage.
Response to Arguments
Applicant’s arguments, see page 4, filed 16 September 2025, with respect to anticipation by the Ujita and Carothers references have been fully considered and are persuasive. The rejection over Ujita has been withdrawn. New grounds of rejection have been raised over Crawford, as discussed above, which substantively address the concerns regarding distance to the occlusion.
Applicant’s remaining arguments have been considered but are not persuasive.
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 PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 1 November 2025