DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim(s) 1 and 3 is/are objected to because of the following informalities:
Change claim 1 line 3 accordingly: “[[a]] the therapeutic medication”
Change claim 1 line 6 accordingly: “the at least one sensor”
Change claim 1 lines 9-10 accordingly: “the at least one sensor”
Change claim 1 line 15 accordingly: “the at least one sensor”
Change claim 3, line 3 accordingly: “from the proximal end to the distal end”
Appropriate correction is required.
Duplicate Claim Warning
Applicant is advised that should claim 9 be found allowable, claim 11 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
Claim(s) 1-20 is/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 1 line 9 recites “in response to data received”. It is unclear if the line 9 data (1) refers to the line 8 data or (2) is different data. For purposes of examination the claim is interpreted regarding the former.
The term “substantially parallel” in claim 3 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Thus the public would not know how much divergence is permitted between the conductor and the lumen regarding claim infringement.
Claim 12 line 3 recites “one or more electrical or optical conductors”. It is unclear if the claim 12 one or more optical conductors are (2) in addition to the claim 1 at least one conductor, or (2) the claim is intended to communicate “one or more electrical or optical conductors of the at least one conductor”. For purposes of examination the claim is interpreted regarding the latter.
Claim 12 recites the limitation "said undercut" in line 2. There is insufficient antecedent basis for this limitation in the claim. There is only antecedent basis for an undercut feature.
The term “substantially enclosing” in claim 13 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Thus the public would not know what the meaning is of substantially enclosing compared to fully enclosing.
Claim 13 recites “situated therein”. It is unclear if therein refers to the protective sheath or the undercut feature.
Claim 14 recites the limitation "the tubing set cross-section" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the highest bending stiffness" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the tubing set cross-section exhibiting the highest bending stiffness" in line 4. The meaning of this phrase appears to be unclear in light of applicant specification. For example, the instant phrase appears to compare the bending stiffness of two or more different cross sections and applicant par. 88 (in sub. spec.) compares the bending stiffness about two different axes of the same cross section. Also, the claim 14 does not recite the maximum stiffness of which cross sections. For purposes of compact prosecution the claim is interpreted regarding applicant par. 88.
Claim 16 recites “a drug delivery apparatus” in line 4. The meaning of the instant term is unclear in light of applicant specification. For example, par. 186 (of PGPub 2024/0358918 par.) states “A drug delivery apparatus or system 285 is provided with … a single lumen tubing set 293 fluidically connected between the fluid pump 292 and patient interface 295”. Further drug delivery system 401 in in fig. 4 appears to include the overall claimed apparatus including controller 403 and tubing set 405. Examiner’s understanding of applicant disclosure is that drug delivery apparatus or drug delivery system refers to the apparatus in the claim 1 preamble. Thus the claim is indefinite because it is not clear what structure the claim 16 apparatus refers to. For purposes of examination the instant term is interpreted to refer to the apparatus in the claim 1 preamble.
Claim 17 recites “the apparatus” in line 2. It is not clear if the claim 17 apparatus refers to the claim 1 apparatus or the claim 16 apparatus.
Claim 20 recites the limitation "the alert" in line 1. There is insufficient antecedent basis for this limitation in the claim. There is only antecedent basis for “the light configured … to alert a user” in claim 16.
Claim 20 recites “the apparatus” in line 2. It is not clear if the claim 20 apparatus refers to the claim 1 apparatus or the claim 16 apparatus. It is noted that apparatus is also recited at claim 20 line 13.
Claim 20 recites the limitation "the status" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "the drug delivery system" in lines 13-14. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites “drug delivery system” in lines 13-14. The meaning of the instant term is unclear in light of applicant specification. For example, par. 186 (of PGPub 2024/0358918 par.) states “A drug delivery apparatus or system 285 is provided with … a single lumen tubing set 293 fluidically connected between the fluid pump 292 and patient interface 295”. Further drug delivery system 401 in in fig. 4 appears to include the overall claimed apparatus including controller 403 and tubing set 405. Examiner’s understanding of applicant disclosure is that drug delivery apparatus or drug delivery system refers to the apparatus in the claim 1 preamble. Thus the claim is indefinite because it is not clear what structure the claim 20 drug delivery system refers to. For purposes of examination the instant term is interpreted to refer to the apparatus in the claim 1 preamble.
Claim 20 line 19 recites “a sensor”. It is unclear if the claim 20 sensor (1) refers to the claim 1 at least one sensor or (2) is a different sensor.
Claims dependent thereon are rejected for the same reasons.
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) 1-3 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2006/0224141 A1 (Rush ‘141) as evidenced by US 6,916,159 (Rush ‘159).
Regarding claim 1, Rush ‘141 discloses (see fig. 6) an apparatus configured to deliver a therapeutic medication to a patient, the apparatus comprising: a reservoir (one of ordinary skill understands that the embodiment of fig. 6 includes a reservoir in the infusion unit 610 and a pump because such infusion unit is connected to infusion tubing set 640 that supplies insulin to the patient; see par. 58; this is evidenced by Rush ‘141 fig. 11B showing reservoir 1120 supplying insulin to infusion tubing set 1100 via pump 1130 and insulin port 1150; this is further discussed in the abstract; this is also evidenced by Rush ‘159 fig. 1B showing reservoir 102 with infusion unit, Rush ‘159 cited in Rush ‘141 par. 72) containing the therapeutic medication (insulin or anther medication; see title and pars. 2-3); and a patient interface (patch 650 at patient skin; see par. 58, bottom) configured to deliver contents of the reservoir into the patient (insulin or suitable medication is delivered to the patient via tubing set 640,670; this is evidenced by pars. 25 and 80); and at least one sensor 660 (it is noted that there can multiple sensors; see par. 32) configured to detect at least one of a physiological aspect of the patient (see par. 24; one of ordinary skill in the art would recognize that this applies to sensor 640) and a physical aspect of the apparatus (see par. 30); a controller 620 (one of ordinary skill in the art would understand unit 620 to be a controller because (1) units 620 and 920 have the same icon and unit 920 is a “control unit”, (2) the unit 620 performs controller functions as discussed in par. 59, and (3) there is no “user interface” regarding fig. 6 embodiment, see par. 58; see discussion of computer type controller in par. 63 and this correlates with the “programming” of pars. 59 and 51; knowledge of the person of ordinary skill in the art in this area is shown in pertinent prior art infra) configured to receive data (see pars. 59 and 48) from the at least one sensor 660, and to start and stop delivery of the therapeutic medication (see pars. 71 and 96) to the patient in response to data received from the at least one sensor (see pars. 71 and 96); and a tubing set (640; it is noted that a tubing set may be a tube; see applicant par. 312 for example) with at least one medication lumen (the medication bore of tubing 640 referred to as “infusion tubing 640”; Rush ‘141 points out in par. 21 and 25 that “infusion tubing 130 [is] for liquid transport or infusion” and “infusion tubing 130 … [is] to deliver medication such as insulin to the patient”) having an internal surface and an external surface (see example tube in fig. 10 showing internal surface at location 1024 and showing opposite external surface), the at least one medication lumen in fluid communication with the reservoir (this is evidenced by fig. 11B showing proximal end of cannula extending from reservoir 1120 towards pump 1130) at a proximal end of the tubing set (the proximal end of tube set portion 640 at infusion unit 610) and the patient interface at a distal end of the tubing set (see distal end of tubing set at patient patch 650), the tubing set also comprising at least one conductor (integral wire in tubing set portion 640, see par. 58) in electrical (RF link 630 extends from controller 620; it is noted that the RF link may be replaced by wires, see par. 72) or optical communication with the controller 620 at the proximal end of the tubing set (RF link is at infusion unit 610 the corresponds with proximal end of tubing set portion 640) and the at least one sensor at a distal end of the tubing set (by way of integral wire in tubing set portion 640 wherein the distal end may be at patch 650 corresponding with sensor 660).
Regarding claim 2, Rush ‘141 discloses (see fig. 6) wherein the at least one conductor is situated internally within the tubing set 640. See par. 58: “tubing 640 having disposed therein integral wires correspondingly connected to the electrodes of analyte sensor 660” (underline emphasis added).
Regarding claim 3, Rush ‘141 discloses the at least one conductor is situated internally (see par. 58: “tubing 640 having disposed therein integral wires correspondingly connected to the electrodes of analyte sensor 660”) within the tubing set 640, and said at least one conductor is substantially parallel to the at least one medication lumen (the medication bore of tubing 640 referred to as “infusion tubing 640”; Rush ‘141 points out in par. 21 and 25 that “infusion tubing 130 [is] for liquid transport or infusion” and “infusion tubing 130 … [is] to deliver medication such as insulin to the patient”) from the proximal end (at infusion unit 610) to the distal end (at patient patch 650) of said tubing set. One of ordinary skill would understand that that the instant ”integral wires” and the instant medication lumen are substantially parallel. This is evidenced by Rush ‘141 figs. 10 and 12B. Fig. 10 shows sensor conductors 1021,1022,1023 substantially parallel with medication lumen at location 1024. Fig. 12B shows cross section of infusion tubing 1220 (referred to as infusion tubing 1020 in par. 76) with sensor medication lumen 1224 and sensor conductors 1221,1222,1223 (referred to as 1021,1022,1023,1024 in par. 76).
Regarding claim 15, Rush ‘141 discloses the tubing set further comprising an optical conductor, wherein the optical conductor comprises an optical fiber. The conductor of applicant claim 1 (i.e., integral wire in tubing set portion 640, see par. 58) may be replaced with “fiber optics” (see par. 77). This fiber optic feature is said to apply to the “present invention” and thus would correspond with the fig. 6 embodiment. The present invention is interpreted to correspond with all the Rush ‘141 embodiments (for example see par. 21: “in one embodiment of the present invention”).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 4 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rush ‘141 as evidenced by Rush ‘159.
Regarding claim 4, Rush ‘141 teaches the current invention as claimed and discussed above. Rush ‘141 embodiment fig. 6 does not teach wherein the at least one conductor is situated on an external surface of the tubing set.
Rush ‘141 embodiment fig. 12C teaches wherein a conductor 1221 is situated on an external surface (of tubing set 1220). It is noted that 1020,1021 are referred to in par. 75 regarding fig. 12C (this is interpreted as a conscription error). It is further noted that “when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 at 1395 (U.S. 2007) (MPEP 2143 I.B.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to substitute location of the conductor of Rush ‘141 fig. 12C for the location of the conductor of fig. 6 (similar to that location in fig. 12B within the tube wall) for the purpose of substituting one known element for another in order to provide the expected result of providing a conductor as part of a tubing set and also to facilitate reducing electronic noise (see Rush ‘141 par. 76).
Regarding claim 10, Rush ‘141 teaches the current invention as claimed and discussed above. Rush ‘141 embodiment fig. 6 does not teach a protective sheath over the at least one conductor on the external surface of the at least medication lumen.
Rush ‘141 embodiment fig. 12C teaches wherein a conductor 1221 is on an external surface (of tubing set 1220). It is noted that 1020,1021 are referred to in par. 75 regarding fig. 12C (this is interpreted as a conscription error). It is further noted that “when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 at 1395 (U.S. 2007) (MPEP 2143 I.B.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to substitute location of the conductor of Rush ‘141 fig. 12C for the location of the conductor of fig. 6 (similar to that location in fig. 12B within the tube wall) for the purpose of substituting one known element for another in order to provide the expected result of providing a conductor as part of a tubing set and also to facilitate reducing electronic noise (see Rush ‘141 par. 76). The teachings of Rush ‘141 embodiment fig. 12C include a protective sheath 1210 over the at least one conductor.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rush ‘141 as evidenced by Rush ‘159, in view of US 20180078195 A1 (Sutaria).
Regarding claim 5, Rush ‘141 teaches the current invention as claimed and discussed above including the at least one conductor situated on the external surface as discussed in the claim 4 analysis. Rush ‘141 does not teach the at least one conductor comprises a conductive ink.
Sutaria teaches a medication (see par. 193) infusion tubing set 102 and further teaches (see figs. 11 and 13) at least one conductor 1301-1308 (situated on the external surface of tube 102) comprises a conductive ink (see par. 203) (such at least one conductor connected to at least one sensor 1101-1108).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to provide Rush ‘141 with the at least one conductor comprises a conductive ink as taught by Sutaria in order to facilitate effective collection of data and ease of manufacture (see Sutaria par. 203). Sutaria points out that such sensor leads may comprise either wires or ink (see par. 175, bottom). This results in at least one of the conductors of Rush ‘141 in view of Sutaria comprising the conductive ink.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rush ‘141 as evidenced by Rush ‘159, in view of US 20220401709 A1 (Beeby) as evidenced by US 11891548 B1 (Johnson).
Regarding claims 6-7, Rush ‘141 teaches the current invention as claimed and discussed above. Rush ‘141 does not teach (claim 6) a barrier coating situated on the internal surface of the at least one medication lumen, the barrier coating further configured to isolate medication within the at least one medication lumen from undesirable extractable or leachable materials from either the tubing set or the at least one conductor; (claim 7) wherein the barrier coating comprises polytetrafluoroethylene.
Beeby teaches a medical tube 502 (see fig. 3) wherein portions of the tube may comprise (see fig. 4 and par. 84, top) a barrier coating 609b situated on an internal surface of a medication lumen 613, the barrier coating further configured to isolate medication (see par. 3 and 7) within the medication lumen from undesirable extractable or leachable materials (barrier 609b serves as an “insulation”, see par. 85, middle and thus one of ordinary skill would understand that such insulation would protect the medication inside the lumen from migration of undesirable materials into the lumen; this is evidenced by Johnson pointing out the PTFE inner layer acts as a “barrier” against bacteria as pointed out at col. 5, ll. 10-15) from either the tubing set or the at least one conductor; wherein the barrier coating comprises polytetrafluoroethylene (see Beeby par. 85).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to provide Rush ‘141 with a barrier coating situated on the internal surface of the at least one medication lumen, the barrier coating further configured to isolate medication within the at least one medication lumen from undesirable extractable or leachable materials from either the tubing set or the at least one conductor; wherein the barrier coating comprises polytetrafluoroethylene as taught by Beeby in order to facilitate providing stiffness for durability and maneuverability (see Beeby par. 85).
Claim(s) 8, 9 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rush ‘141 as evidenced by Rush ‘159, in view of US 20200281503 A1 (Salamini).
Regarding claim 8, Rush ‘141 embodiment of fig. 6 does not teach a barrier coating interposed between the at least one conductor and the external surface of the at least one medication lumen.
Rush ‘141 embodiment fig. 12C teaches between the at least one conductor and the external surface of the at least one medication lumen (i.e., a conductor 1221 is situated on an external surface (of tubing set 1220). It is noted that 1020,1021 are referred to in par. 75 regarding fig. 12C (this is interpreted as a conscription error). It is further noted that “when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 at 1395 (U.S. 2007) (MPEP 2143 I.B.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to substitute location of the conductor of Rush ‘141 fig. 12C for the location of the conductor of fig. 6 (similar to that location in fig. 12B within the tube wall) for the purpose of substituting one known element for another in order to provide the expected result of providing a conductor as part of a tubing set and also to facilitate reducing electronic noise (see Rush ‘141 par. 76).
Salamini teaches an apparatus for medication infusion (see pars. 15 and 16) and further teaches (see fig. 25A) a barrier coating (see PTFE coating in par. 192) and an external surface (the instant barrier coating is on the outer surface of tube 2502 discussed in pars. 182,184; see cross section showing outer surface in for example fig. 37A) of the at least one lumen 2518.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to provide Rush ‘141 with a barrier coating interposed between the at least one conductor and the external surface of the at least one medication lumen as taught by Salamini in order to facilitate insulating Rush ‘141 tube 649 from water based contaminants (see Salamini par. 239). One of ordinary skill in the art is knowledgeable that PTFE repels water (see pertinent prior art infra).
Regarding claims 9 and 11, Rush ‘141 in view of Salamini teach the current invention as claimed and discussed above. The teachings of Salamini applied in the claim 8 analysis above include (claims 9 and 11) (see par. 193) wherein the barrier coating comprises polytetrafluoroethylene (see PTFE in par. 193.
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rush ‘141 as evidenced by Rush ‘159, in view of US 5085657 (Ben-Simhon).
Regarding claim 12, Rush ‘141 teaches the current invention as claimed and discussed above. Rush ‘141 embodiment fig. 6 does not teach an undercut feature situated on an exterior contour of the tubing set, said undercut containing one or more electrical or optical conductors.
Rush ‘141 embodiment fig. 12C teaches a feature (circumferential outer wall of tube 10201,1220 in fig. 12C) situated on an exterior contour of a tubing set 1020,1220, said feature containing one or more electrical 1220,1221 or optical conductors. It is noted that 1020,1021 are referred to in par. 75 regarding fig. 12C (this is interpreted as a conscription error). It is further noted that “when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 at 1395 (U.S. 2007) (MPEP 2143 I.B.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to substitute location of the conductor of Rush ‘141 fig. 12C for the location of the conductor of fig. 6 (similar to that location in fig. 12B within the tube wall) for the purpose of substituting one known element for another in order to provide the expected result of providing a conductor as part of a tubing set and also to facilitate reducing electronic noise (see Rush ‘141 par. 76).
Ben-Simhon teaches (see figs. 1 and 6B) a medical device (electrical surgical scalpel 18) and further teaches a feature (situated on an exterior contour (see fig. 6B) of a tubing set 10) is an undercut feature 120 (wire 20 resides in groove 120; see col. 8, l. 65 to col. 9, l. 5; see “electric wire 20” at col. 4, ll. 15-20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to provide Rush ‘141 with the feature is an undercut feature as taught by Ben-Simhon in order to facilitate a more compact medical device.
Regarding claim 13, Rush ‘141 in view of Ben-Simhon teach the current invention as claimed and discussed above. Rush ‘141 further teaches (see fig. 12C, in consideration of Ben-Simhon’s teachings) a protective sheath 1210 substantially enclosing the undercut feature (as taught by Ben-Simhon in the claim 12 analysis above) and any electrical 1220,1221 or optical conductors situated therein.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rush ‘141 as evidenced by Rush ‘159, in view of US 20030191491 A1 (Duane) as evidenced by US 6763730 B1 (Wray), and Ben-Simhon.
Regarding claim 14, Rush ‘141 teaches the current invention as claimed and discussed above. Rush ‘141 does not teach wherein the tubing set comprises an asymmetric cross-section with an undercut feature containing one or more electrical or optical conductors, the undercut feature further being situated in the tubing set cross-section exhibiting the highest bending stiffness.
Duane teaches a tube set 30 including a fluid lumen 42 and a wire 15 lumen 46(see title) and further teaches (see figs. 7, 11B and 11A) the tubing set 30 comprises an asymmetric cross-section (see fig. 11B) with a feature (rounded outer edge at the most upward portion of fig. 11B) containing a conductor 15, the feature further being situated in the tubing set cross-section exhibiting the highest bending stiffness (this is evidenced by Wray col. 5, ll. 49-55; Wray teaches a Coriolis tube, see col. 10, ll. 1-5, such Coriolis tubes used in the medical device arts as discussed in pertinent prior art infra; also see 112 section above). Duane points out that tube sets may be either cylindrical or oval cross sections (see par. 56, bottom). It is further noted that “when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 at 1395 (U.S. 2007) (MPEP 2143 I.B.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to substitute the cross section shape of Rush ‘141 fig. 6 tubing set 640 for Duane fig. 11B oval cross section shape for the purpose of substituting one known element for another in order to provide the expected result of providing a dual lumen tube set for fluid delivery and conductor of Rush ‘141 in view of Duane. The claim requires one medication lumen and one conductor.
Ben-Simhon teaches (see figs. 1 and 6B) a medical device (electrical surgical scalpel 18) and further teaches a feature (situated on an exterior contour (see fig. 6B) of a tubing set 10) is an undercut feature 120 (wire 20 resides in groove 120; see col. 8, l. 65 to col. 9, l. 5; see “electric wire 20” at col. 4, ll. 15-20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to provide Rush ‘141 in view of Duane with the feature is an undercut feature as taught by Ben-Simhon in order to facilitate a more compact medical device.
Claim(s) 16 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rush ‘141 as evidenced by Rush ‘159, US 5695473 (Olsen) and US 20080294108 A1 (Briones), in view of US RE33021 E (Danby).
Regarding claim 16, Rush ‘141 discloses the tubing set further comprising an optical conductor (the “integral wires” of par. 58 may be optical fiber; see par. 77) and alert a user as to an aspect or status of a drug delivery apparatus connected to the tubing set (see pars. 30-31; wherein Rush ‘141 alerts user of occlusion of tubing set; ). Rush ‘141 does not disclose the controller 620 comprising at least one light disposed therein, the light configured to operate in conjunction with the optical conductor to alert the user to the aspect.
Danby teaches an infusion apparatus (see title) and further teaches (see col. 4, ll. 47 to col. 5, l. 5) a controller comprising at least one light disposed therein, the light configured to operate in conjunction with (a sensor). Rush ‘141 teaches a sensor providing light along fiber optic cable (see par. 77). Olsen (claim 14) is evidence that Rush ‘141’s occlusion detection can be by a sensor associated with the tubing set 640.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to provide Rush ‘141 embodiment fig. 6 with the controller 620 comprising at least one light disposed therein, the light configured to operate in conjunction with the optical conductor to alert the user to the aspect as taught by Rush ‘141 and Danby in order to facilitate using reliable conventional sensor communication in order to alert user of undesired health related scenario (i.e. blockage of insulin to patient). The Rush ‘141 occlusion sensor (as evidenced by Olsen) associated with the tubing set 640 communicates an occlusion condition via fiber optics as taught by Rush ‘141 and Danby to controller 620 wherein the light from the instant fiber optics cable enters the controller 620 as taught by Danby. Because the tubing set is occluded the status regarding the insulin delivery pump is limited status for example (this is evidenced by Briones par. 159, bottom).
Regarding claim 20, Rush ‘141 in view of Danby teach the current invention as claimed and discussed above. Rush ‘141 teaches wherein the alert presented to a user of the apparatus comprises a signal as to the status of a drug delivery device connected to the tubing set, selected from one of the group of a) the drug delivery device is properly configured, b) the drug delivery device is ready to administer medication to a patient, c) the drug delivery device is currently administering one or more medications to a patient, d) the drug delivery device detected an error in configuration prior to administration, e) the drug delivery device detected an error during administration of one or more medications by the drug delivery device, f) the drug delivery device has completed medication administration, g) the drug delivery device has detected administration taking place at an unsafe rate, h) the drug delivery device has detected loss of skin contact at the patient interface, i) the drug delivery device has detected disconnection from or occlusion of the patient interface, or j) the tubing set in the apparatus is incorrect or incompatible with the medication within the drug delivery system, k) the drug delivery device has detected a suspected infusion reaction, 1) the drug delivery device has detected anomalous physiologic sensor data, m) the drug delivery device has detected a tubing set occlusion (see Rush ‘141 par. 30), n) the patient interface is incorrectly configured, o) the drug delivery system has administered an emergency medication to a patient, p) the drug delivery system has a low battery level, q) the drug delivery system has lost connection to a sensor, r) the drug delivery system has lost connectivity to an external system or server, s) the drug delivery system has an expired medication or component, t) the drug delivery system has administered a pre-medication, u) the drug delivery system has administered a post-medication, v) the drug delivery system has lost connection to a telemedicine service, w) the drug delivery system has lost wireless connection, or x) the drug delivery system has lost cellular connection.
Claim(s) 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rush ‘141 as evidenced by Rush ‘159, Olsen and Briones; in view of Danby as applied to claim 16 above, and further in view of US 20200261644 A1 (Farnan).
Regarding claims 17-19, Rush ‘141 in view of Danby teach the current invention as claimed and discussed above. Rush ‘141 does not teach (claim 17) an illuminated alert to a user of the apparatus; (claim 18) an illuminated alert presented to a user as a color code including different colors; and (claim 19) an illuminated alert presented to a user as a pulsed pattern of one or more different colors.
Farnan teaches an insulin infusion apparatus (see par. 4) and further teaches (see pars. ) an illuminated (see par. 38) alert (alert regarding occlusion; see “Occlusion Alarm screen 212” in par. 38) to a user of the apparatus; an illuminated alert presented to a user as a color code including different colors (see par. 29: “any number of patterns, frequencies, durations, sequences, combinations, colors, brightness levels, etc”); and an illuminated alert presented to a user as a pulsed pattern (see par. 38) of one or more different colors.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to provide Rush ‘141 in view of Danby with an illuminated alert to a user of the apparatus; (claim 18) an illuminated alert presented to a user as a color code including different colors; and (claim 19) an illuminated alert presented to a user as a pulsed pattern of one or more different colors as taught by Farnan in order to facilitate prompting the user to address various scenarios of the infusion device (see Farnan pars. 29 and 37.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.:
“electrical communication via RF links” (claim 67): US 20030013974
PTFE repels water (par. 7): US 20110318575
Coriolis meter for infusion device (par. 71): US 20080058758
Say (US 6175752) explains that the type of analytic monitoring units (such as units 120 and 620 in figs. 1 and 6 or Rush ‘141, respectively) of Rush ‘141 (US 2006/0224141) are computer controllers that start and stop medication (see Say col. 54, ll. 50-60) wherein Say is cited at Rush ‘141 par. 27.
Conclusion
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/MARC AMAR/Examiner, Art Unit 3741 /DEVON C KRAMER/Supervisory Patent Examiner, Art Unit 3741
1 See par. 76.
