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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Species A and Subspecies 1 in the reply filed on 2/3/2026 is acknowledged. Although Applicant indicated that claim 8 reads upon the election, this claim actually is directed to non-elected Subspecies 4 (due to it claiming that the sensor is a micro-electromechanical system (MEMS) device). Accordingly, claims 6-8 and 17-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (claims 17-20) or subspecies (claims 6-8), there being no allowable generic or linking claim.
Claim Objections
Claim 12 is objected to because of the following informalities: The term “the” should be inserted before the term “detected” on line 2 in order to be grammatically correct. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: The term “on” should be removed from the phrase “use on historical profiles” on line 2 in order to be grammatically correct. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: The term “a” should be inserted before the term “notification” on line 3 in order to be grammatically correct. The phase “the volume of insulin” on line 3 lacks proper antecedent basis because it is the first time this “volume” has been introduced in the claimed and is grammatically incorrect since the “insulin” has been introduced earlier in the claim; accordingly, the phrase “the volume of insulin” should be amended to recite “[[the]] a volume of the insulin” in order to ensure proper antecedent basis. 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 14-16 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.
Claim 14 recites “a confidence in the detection and classification of the occlusion” on line 3. Claim 12 introduces “classifications”, but claim 14 does not depend on claim 12; because of this, it is unclear if claim 14 was intended to depend directly on claim 12, if claim 13 (which claim 12 depends directly on) was intended to depend directly on claim 12, or if claim 14 was intended to introduce “classifications”. Claim 14 depends on claim 11 which introduces “occlusions” (plural) while claim 14 refers to “the occlusion” (singular); because of this, it is unclear if claim 14 intended to refer to the “occlusions” (plural) of claim 11, intended to refer to a single one of the “occlusions” of claim 11, or intended to introduce an “occlusion”. For the sake of examination, claim 14 is interpreted as referring to the “classifications” of claim 12 and the “occlusions” of claim 11. Accordingly, it is suggested to amend claim 13 (which claim 14 depends on) to depend on claim 12 and to amend claim 14 to recite “a confidence in the detection and the classification of the occlusions”. Claims 15 and 16 are rejected due to their dependence on claim 14.
Claim 15 recites “the detected occlusion” on line 2. Claim 15 depends on claim 11 which introduces “occlusions” (plural) while claim 15 refers to “the detected occlusion” (singular); because of this, it is unclear if claim 15 intended to refer to the “occlusions” (plural) of claim 11, intended to refer to a single one of the “occlusions” of claim 11, or intended to introduce an “occlusion”. For the sake of examination, claim 15 is interpreted as referring to the “occlusions” of claim 11. Accordingly, it is suggested to amend claim 15 to recite “the detected occlusions”. Claim 16 is rejected due to its dependence on claim 15.
Claim 16 recites “wherein the liquid drug is insulin” on line 1. The phase “liquid drug” has not been recited earlier in the claim and, therefore, lacks proper antecedent basis. Since no “liquid”, “drug”, or even “fluid” has been introduced earlier in the claim, it is unclear how the “liquid drug” is intended to relate to the other features recited in the claims. For the sake of examination, claim 16 is interpreted as requiring the fluid path to be configured to deliver a liquid drug in the form of insulin to a user. Accordingly, it is suggested to amend line 1 to recite “The device of claim 15, wherein the fluid path is configured to deliver to a user”.
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.
Claims 1-4 and 9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Momose (PG PUB 2015/0209511).
Re claim 1, Momose discloses a device 1 (Fig 1) for detecting changes in pressure in a fluid path (the fluid path extending from reservoir 30 to outlet port assembly 70 in Fig 2) (Para 57) comprising: a length of tubing 92 (Fig 1) connected in-line with the fluid path (as seen in Fig 2, the tubing 92 is connected to tubing 91 which connects to the reservoir 30 and the outlet port assembly 70); and a sensor 100 (Fig 2,3,4) operable to detect flex of the length of tubing (Para 49).
Re claim 2, Momose discloses that the sensor comprises a flexible member 132 (Fig 3,4; as seen in Fig 4, the member 132 flexes when acted upon by member 131 when the tubing 92 is expanded) disposed on the length of tubing (as seen in Fig 3,4).
Re claim 2, Momose discloses that the sensor comprises: a rigid enclosure 140+150 (Fig 3,4) surrounding the length of tubing (as seen in Fig 3,4); a flexible region 132 defined in a wall of the rigid enclosure (as seen in Fig 3,4, the flexible region is in wall 130; as seen in Fig 4, the member 132 flexes when acted upon by member 131 when the tubing 92 is expanded); and a fluid disposed in the rigid enclosure (because the contents of lid member 140 when attached to base member 150 are not in vacuum, air (which is a fluid) is within the enclosure 140+150), wherein the sensor is operable to detect the flex of the length of tubing by detecting flex of the flexible region of the rigid enclosure (Para 57).
Re claim 4, Momose discloses that the length of tubing is constructed of a material more compliant than the material of which the rest of the fluid path is constructed (Para 60) such that a buildup of pressure within the fluid path caused by an occlusion in the fluid path causes the length of tubing to expand (Para 47), wherein expansion of the length of tubing is communicated to the flexible region by the fluid (the air (the fluid) contained within enclosure 140 allows for pressure transmitting plate 170 to move upward by expansion of the tubing and this upward movement causes spherical member 131 to move upward and act of flexible region 132, as seen in Fig 3 and 4 and Para 57,58).
Re claim 9, Momose discloses that the sensor is configured to output a time series of readings indicative of changes in pressure within the fluid path (Fig 5 and Para 64 set forth that a first reading is taken (step S204 in Fig 5) and, if the reading does not exceed a reference value that indicates a clogged condition (“NO” in Fig 5), then a second reading is taken and so on (step S204 again in Fig 5).
Re claim 10, Momose discloses a processor 50 (Fig 2) operable to receive the time series of readings from the sensor (Para 45,64) and form a pressure profile of the pressure within the fluid path (Para 64,65; wherein the “pressure profile” is that of a downstream section of the flow path being occluded or not).
Re claim 11, Momose discloses that the processor is further operable to detect occlusions in the fluid path based on the time series of readings (Para 65).
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Momose (PG PUB 20150209511) in view of Burke et al. (PG PUB 2018/0318503).
Re claim 5, Momose discloses that the flexible region comprises “any type of pressure sensor” (Para 74) but does not explicitly disclose that the pressure sensor is a strain gauge wherein a resistance of the strain gauge changes as the flexible region flexes and the sensor is operable to sense the changes in the resistance. Burke, however, teaches using a pressure sensor 301 (Fig 3) in the form of a strain gauge (Para 40) wherein a resistance of the strain gauge changes as a flexible region 40 (Fig 3) flexes as a result of increased pressure in a fluid path 57 (Fig 3) (Para 41) and the sensor is operable to sense the changes in the resistance (Para 41) for the purpose of converting the mechanical strain exhibited by the flexible region to a proportional electrical signal that can be used by a processor to determine degree of flexing as a function of time (Para 41). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Momose to include the pressure sensor as a strain gauge, as taught by Burke, for the purpose of converting the mechanical strain exhibited by the flexible region to a proportional electrical signal that can be used by the processor to determine degree of flexing as a function of time (Para 41).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Momose (PG PUB 2015/0209511) in view of Neftel et al. (PG PUB 2018/0214634).
Re claim 12, Momose discloses all the claimed features except that the processor is further operable to classify detected occlusions in the fluid path as full occlusions or partial occlusions. Neftel, however, teaches a processor that is operable to classify detected occlusions in a fluid path as full occlusions or partial occlusions (Para 24) for the purpose of determining how much of the fluid has been infused, or not-infused, by the system (since a partial occlusion would result in some fluid being infused while a full occlusion would result in no fluid being infused) and to control the system appropriately (Para 24,138). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Momose to include the processor so that it is operable to classify detected occlusions in the fluid path as full occlusions or partial occlusions, as taught by Neftel, for the purpose of determining how much of the fluid has been infused, not-infused, by the system and to control the system appropriately (Para 24,138).
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Momose (PG PUB 20150209511)/Neftel et al. (PG PUB 2018/0214634)1 in view of Estes (PG PUB 2009/0275887).
Re claim 13, Momose discloses all the claimed features except that the processor is operable to use historical profiles indicating changes in glucose readings based on a given amount of insulin being delivered in the detection of the occlusions (as required by claim 13), to receive blood glucose readings and utilize the blood glucose readings to determine a confidence in the detection and classification of the occlusion (as required by claim 14) and to generate a notification of the detected occlusion (as required by claim 15). Estes, however, teaches a device comprising a processor that uses historical profiles that indicate changes in glucose readings based on a given amount of insulin being delivered in order to detect occlusions in a fluid path (“if the glucose level is greater than the threshold level”, Para 90), wherein the processor receives and uses blood glucose readings to determine a confidence in the detection and classification of the occlusions (“the sensitivity of the occlusion detection system is increased”, Para 90) and generates a notification of the detected occlusions (“the user is more promptly alerted”, Para 90) for the purpose of ensuring that the user is more promptly alerted to possible occlusions when blood glucose levels are higher than the normal range and insulin dispensation is an urgent concern (Para 8,90) Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Momose to include the processor such that it uses historical profiles indicating changes in glucose readings in the detection of the occlusions, uses blood glucose readings to determine confidence in the detection and classification of the occlusions, and generates a notification of the detected occlusions, as taught by Estes, for the purpose of ensuring that the user is more promptly alerted to possible occlusions when blood glucose levels are higher than the normal range and insulin dispensation is an urgent concern (Para 8,90).
Claims 16 is rejected under 35 U.S.C. 103 as being unpatentable over Momose (PG PUB 2015/0209511)/Estes (PG PUB 2009/0275887) in view of Blomquist et al. (PG PUB 2009/0275886).
Re claim 16, Momose discloses that the fluid path is configured to deliver insulin to a user (it is noted that the phrase “configured to deliver insulin to a user” is a functional limitation and, therefore, the fluid path of the claim only has to be structurally capable of delivering insulin to a user; since Momose discloses that the fluid path carries liquid – Para 40 – it is “configured to” deliver insulin)) but Momose/Estes are silent as to the processor being operable to generation a notification when a volume of the insulin delivered to the user is reduced by a preset amount. Blomquist, however, teaches a processor operable to generate notification when a volume of insulin delivered to a user is reduced by a preset amount (Para 62) for the purpose of ensuring that the user is aware of the change (Para 58). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed was made to modify Momose to include the processor such that it is operable to generate a notification when a volume of the insulin delivered to the user is reduced by a preset amount, as taught by Blomquist, for the purpose of ensuring the user is aware of the change (Para 58).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Pat 4,277,227 to Jenkins, US Pat 4,836,752 to Burkett, PG PUB 2008/0021395 to Yodfat et al., PG PUB 2009/0118667 to Hauerter et al., PG PUB 2015/0064036 to Eberhard and PG PUB 2016/0184517 to Baek et al. each read on at least independent claim 1.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 As set forth in the 112(b) rejection of claim 14 above, claim 13 is interpreted as depending on claim 12 (instead of claim 11) due to claim 12 providing antecedent basis for the “classification” of claim 14.