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 Objections
Claim 17 is objected to because of the following informalities: Lines 9-10 are grammatically incorrect. In order to be grammatically correct, they should be amended to recite “when de-mating the cap from and mating the cap [[from]] to the receptacle”. Appropriate correction is required.
Claim 30 is objected to because of the following informalities: Lines 9-11 are grammatically incorrect. In order to be grammatically correct, they should be amended to recite “when de-mating the cap from and mating the cap [[from]] to the receptacle”. 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 17-36 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 17 sets forth that the method involves “a fluid delivery device” in the preamble, but then does not recite this device again. It is unclear how the “housing”, “reservoir of fluid”, “receptacle”, “cap” and “connectors” of the claim relate to the “fluid delivery device” – that is, are these structures components of the “fluid delivery device” or not? For the sake of examination, the “housing” and the “receptacle” are interpreted as being components of the “fluid delivery device”. Accordingly, it is suggested to amend lines 3-4 to recite “providing (i) the fluid delivery device comprising a housing having a receptacle for supporting a reservoir of fluid, the receptacle having an inner surface”. Claims 18-29 are rejected due to their dependence on claim 17.
Claim 17 set forth two cap connectors (“a pair of mating interlocking connectors comprising cap connectors”) on lines 5-6. Lines 7-8 state “the cap connectors having a flexible arm and a finger”; due to the language of lines 7-8 it is unclear if each of the cap connectors has its own flexible arm and its own finger or if the combination of the two cap connectors include a flexible arm and its own finger (i.e. if only one of the cap connectors has these features while the other of the cap connectors does not). Additionally, the recitation of “the flexible arm” on line 9, “the urged flexible arm” on lines 11 and 13, and “the finger” on lines 12 and 13 also render it unclear whether the steps of lines 9-14 involve just one flexible arm and one finger or both flexible arms and both fingers. Based on the original disclosure, it appears that each cap connector has its own flexible arm and its own finger and that the steps of lines 9-14 involve one of the arms and one of the fingers; therefore, this is the interpretation applied for the sake of examination. Accordingly, it is suggested to amend lines 5-14 to recite:
“(iii) a pair of mating interlocking connectors comprising cap connectors provided on the cap and receptacle connectors provided on the receptacle, the cap connectors each having a flexible arm and a finger extending outwardly from the respective flexible arm, each [[the]] flexible arm is urged inwardly when de-mating the cap from and mating the cap [[from]] to the receptacle until a locked position is reached;
detecting a first force from a first of the urged flexible arms while [[the]] its finger is engaged with the inner surface of the receptacle;
detecting a second force from the first urged flexible arm while [[the]] its finger is engaged outwardly in the locked position”.1
Claims 18-29 are rejected due to their dependence on claim 17.
Claim 18 recites “the detecting” on line 1. Since claim 17 has been amended to recite two steps of “detecting” (see line 11 and line 13), it is unclear if “the detecting” of claim 18 is intended to refer to one of these two steps – and if so, which one – or to refer to both of these two steps. For the sake of examination, “the detecting” of claim 18 is interpreted as referring to both of the “detecting” steps of claim 17. Accordingly, it is suggested to amend line 1 of claim 18 to recite “wherein the detecting the first force and the detecting the second force”.
Claims 22-27 each recite “the finger” and claims 24-27 each recite “the urged flexible arm”. Since claim 17 introduces two fingers and two urged flexible arms, it is unclear which of these the phrase “the finger” and the phrase “the urged flexible arm” are intended to refer to or if these phrases are intended to refer to both of the fingers and both of the flexible arms. For the sake of examination, the “finger” and the “flexible arm” of each of these claims are interpreted as being those used in the “detecting” steps of claim 17. Accordingly, it is suggested to amend each recitation of “the finger” to recite “the finger of the first urged flexible arm” and to amend each recitation of “the urged flexible arm” to recite “the first urged flexible arm”. Claims 28 and 29 are rejected due to their dependence on claim 27.
Claim 30 sets forth that the method involves “a fluid delivery device” in the preamble, but then does not recite this device again. It is unclear how the “housing”, “reservoir of fluid”, “receptacle”, “cap” and “connectors” of the claim relate to the “fluid delivery device” – that is, are these structures components of the “fluid delivery device” or not? For the sake of examination, the “housing” and the “receptacle” are interpreted as being components of the “fluid delivery device”. Accordingly, it is suggested to amend lines 3-4 to recite “providing (i) the fluid delivery device comprising a housing having a receptacle for supporting a reservoir of fluid, the receptacle having an inner surface”. Claims 31-36 are rejected due to their dependence on claim 30.
Claim 30 sets forth two cap connectors (“a pair of mating interlocking connectors comprising cap connectors”) on line 6. Lines 7-9 state “the cap connectors having a flexible arm and a finger”; due to the language of lines 7-9 it is unclear if each of the cap connectors has its own flexible arm and its own finger or if the combination of the two cap connectors include a flexible arm and its own finger (i.e. if only one of the cap connectors has these features while the other of the cap connectors does not). Additionally, the recitation of “the flexible arm” on line 9, “the urged flexible arm” on lines 12 and 15, and “the finger” on lines 13 and 15 also render it unclear whether the steps of lines 9-14 involve just one flexible arm and one finger or both flexible arms and both fingers. Based on the original disclosure, it appears that each cap connector has its own flexible arm and its own finger and that the steps of lines 9-16 involve one of the arms and one of the fingers; therefore, this is the interpretation applied for the sake of examination. Accordingly, it is suggested to amend lines 6-16 to recite:
“(iv) a pair of mating interlocking connectors comprising cap connectors provided on the cap and receptacle connectors provided on the receptacle, the cap connectors each having a flexible arm and a finger extending outwardly from the respective flexible arm, each [[the]] flexible arm is urged inwardly when de-mating the cap from and mating the cap [[from]] to the receptacle until a locked position is reached;
detecting a first force from a first of the urged flexible arms with the sensor while [[the]] its finger is engaged with the inner surface of the receptacle;
detecting a second force from the first urged flexible arm with the sensor while [[the]] its finger is engaged outwardly in the locked position”.2
Claims 31-36 are rejected due to their dependence on claim 30.
Claims 32, 33, 35 and 36 each recite “the finger” and claims 33-36 each recite “the urged flexible arm”. Since claim 30 introduces two fingers and two urged flexible arms, it is unclear which of these the phrase “the finger” and the phrase “the urged flexible arm” are intended to refer to or if these phrases are intended to refer to both of the fingers and both of the flexible arms. For the sake of examination, the “finger” and the “flexible arm” of each of these claims are interpreted as being those used in the “detecting” steps of claim 30. Accordingly, it is suggested to amend each recitation of “the finger” to recite “the finger of the first urged flexible arm” and to amend each recitation of “the urged flexible arm” to recite “the first urged flexible arm”.
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.
Claims 17-36 are rejected under 35 U.S.C. 103 as being unpatentable over Pananen et al. (PG PUB 2016/0015885) in view of Engelhard et al. (WO 2015/031472)3.
Re claim 17, Pananen discloses a method of detecting user mating/de-mating of a cap 704 and a delivery tube 50 with a fluid delivery device 30 (Para 912; the method utilizes the cap 704 shown in Fig 43-47; it is noted that all reference characters cited below refer to Fig 1 and/or Fig 43-47), comprising: providing (i) a housing 33 having a receptacle 32 for supporting a reservoir of fluid, the receptacle having an inner surface (Para 374), (ii) the cap 704 with the delivery tube 50 configured to removably mate with the receptacle (Para 899), and (iii) a pair of mating interlocking connectors comprising cap connectors 700,700 provided on the cap and receptacle connectors 32d,32d provided on the receptacle (Para 893), the cap connectors having a flexible arm (the portion of connector 700 from which 702 extends in Fig 44) and a finger 702 extending outwardly from the flexible arm (as seen in Fig 44), the flexible arm is urged inwardly when de-mating and mating the cap from the receptacle until a locked position is reached (Para 900,902); detecting a first force from the urged flexible arms while the finger is engaged with the inner surface of the receptacle (via sensor 70+91+93, Para 551; Para 911 sets forth that “one or more (or all) of the extensions 700 of the cap is provided with one or more detectable elements 42 described above” and that “the infusion pump device 30 may include one or more corresponding sensor elements described above, arranged to detect the detectable elements 42, for example, when extensions 700 are engaged with the ramp portion 32c, or when the extensions are engaged with the stop surface 32d, or when the extensions are flexed (or a combination thereof)”); and detecting a second force from the urged flexible arm while the finger is engaged in the locked position (via sensor 70+91+93, Para 551; Para 911 sets forth that “one or more (or all) of the extensions 700 of the cap is provided with one or more detectable elements 42 described above” and that “the infusion pump device 30 may include one or more corresponding sensor elements described above, arranged to detect the detectable elements 42, for example, when extensions 700 are engaged with the ramp portion 32c, or when the extensions are engaged with the stop surface 32d, or when the extensions are flexed (or a combination thereof)”). Although Pananen discloses recording in a memory 66 (Fig 5) the condition or state of the cap as a result of detected forces (Para 506), Pananen does not disclose recording the detected forces itself.
Engelhard, however, teaches providing a force sensor 446 (Fig 8, Para 136) on a first component 404 (Fig 9; wherein sensor 446 is a component of processor assembly 420 of Fig 9, Para 134; comparable to the receptacle of the housing of Pananen) that detects force from a second component 406 (Fig 9; comparable to the flexible arm of the cap of Pananen) when the force sensor is contacted by the second component (comparable to when the housing and the cap are mated/locked to each other in Pananen) and when the force sensor is no longer contacted by the second component (comparable to when the housing and the cap are de-mated/not locked to each other in Pananen) (Para 136) and recording the detected force in a memory (of processor 441, Para 134) since the recording of the detected force – as opposed to recording of just the result of the detected force, as in Pananen – helps to eliminate false positives (Para 137). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Pananen to record the detected forces themselves, as taught by Engelhard, for the purpose of aiding in eliminating false positives (Para 137).
Re claim 18, Pananen discloses that the detecting comprises detecting pressure exerted from the urged flexible arm against the inner surface of the receptacle (Para 551), but does not disclose that detecting the pressure requires “measuring” the pressure. Engelhard, however, teaching that the detecting of the pressure comprises measuring pressure exerted from the second component against the first component (Para 136). As set forth in the rejection of claim 17 above, the first component is comparable to the receptacle of the housing of Pananen and the second component is comparable to the flexible arm of the cap of Pananen. The motivation set forth in the rejection of claim 30 also applies to this claim.
Re claim 19, Pananen discloses that the first force and the second force are unequal (Para 551, 911; if the two forces were the same, then the processor of the device would not be able to detect between the locked position and the unlocked position).
Re claim 20, Pananen discloses determining a locked condition of the cap to the housing (Para 622), but does not disclose that this is done by comparing the detected second force with a known force indicative of the cap locked onto the housing. However, as set forth in the rejection of claim 17 above, Engelhard teaches comparing a detected force with a known force indicative of a second component being contacted by a first component in order to determine contact of the second component with the first component (Para 137). As set forth in the rejection of claim 17 above, the first component is comparable to the receptacle of the housing of Pananen, the second component is comparable to the flexible arm of the cap of Pananen, and the first component contacting the second component is comparable to the locked state of Pananen. The motivation set forth in the rejection of claim 17 also applies to this claim.
Re claim 21, Pananen discloses authenticating the cap by comparing the recorded data pertaining to the second force with an acceptable set of data (Para 543, “compare parameters of a detected signal (or a detected target signature) with stored parameters”; Para 544, “the stored data may include, but is not limited to, data corresponding to […] manufacturers of the caps”), but does not disclose that the recorded data is the detected force and that the acceptable set of data is an acceptable range of forces. However, as set forth in the rejection of claim 17 above, Engelhard teaches comparing a detected force with an acceptable range of forces (Para 137). The motivation set forth in the rejection of claim 17 also applies to this claim.
Re claim 22, Pananen discloses providing a detents 32d in the receptacle, the detect being configured to receive the finger in interlocked engagement (Para 893).
Re claim 23, Pananen discloses locking the cap within the receptacle by receiving the finger within the detent in the receptacle (Para 893).
Re claim 24, Pananen discloses providing a pressure sensor 70+91+93 (Fig 10,11) within a recess 32c (Fig 47) proximate the detent (Para 911 sets forth “the infusion pump device 30 may include one or more corresponding sensor elements described above, arranged to detect the detectable elements 42, for example, when extensions 700 are engaged with the ramp portion 32c”), wherein detecting the first force from the urged flexible arm comprises detecting pressure of the urged flexible arm against the pressure sensor prior to the finger engaging within the detent (since the recess 32c precedes the detent 32d, as seen in Fig 47 and Para 897).
Re claim 25, Pananen discloses that the detected pressure of the urged flexible arm against the pressure sensor prior to the finger engaging with the detent indicates an unlocked state (since the recess 32c precedes the detent 32d, as seen in Fig 37 and Para 897).
Re claim 26, Pananen discloses that detecting the second force from the urged flexible arm comprises detecting pressure of the urged flexible arm against the pressure sensor when the finger engages with the detent (since the outer surface of the arm would directly contact the recess 32c when the finger 702 is in the detect 32d, as seen in Fig 45, member 70 of the sensor would be pushed by the outer surface of the arm, as seen in Fig 11).
Re claim 27, Pananen discloses that the detected pressure of the urged flexible arm against the pressure sensor when the finger engages with the detent indicates a locked state (Para 893).
Re claim 28, Pananen discloses detecting whether the cap is in the locked state relative to the receptacle based by comparing the data recorded in the memory regarding the second force with a set of data indicative of the locked state (Para 543, “compare parameters of a detected signal (or a detected target signature) with stored parameters”; Para 544), but does not disclose that the recorded data is the detected force and that the acceptable set of data is a range of forces. However, as set forth in the rejection of claim 17 above, Engelhard teaches comparing a detected force with an acceptable range of forces in order to determine the first component is in contact with the second component (Para 137). As set forth in the rejection of claim 17 above, the first component is comparable to the receptacle of the housing of Pananen, the second component is comparable to the flexible arm of the cap of Pananen, and the first component contacting the second component is comparable to the locked state of Pananen. The motivation set forth in the rejection of claim 17 also applies to this claim.
Re claim 29, Pananen discloses authenticating the cap by detecting whether the cap is an after-market cap by comparing one of the unlocked state and the locked state with a known set of data corresponding with an authentic cap (Para 543, “compare parameters of a detected signal (or a detected target signature) with stored parameters and obtain from the stored data”; Para 544, “the stored data may include, but is not limited to, data corresponding to […] manufacturers of the caps”), but does not disclose that the known set of data is a known range of forces. However, as set forth in the rejection of claim 17 above, Engelhard teaches comparing a detected force with an known range of forces (Para 137). The motivation set forth in the rejection of claim 17 also applies to this claim.
Re claim 30, Pananen discloses a method of detecting user mating/de-mating of a cap 704 and a delivery tube 50 with a fluid delivery device 30 (Para 912; the method utilizes the cap 704 shown in Fig 43-47; it is noted that all reference characters cited below refer to Fig 1 and/or Fig 43-47), comprising: providing (i) a housing 33 having a receptacle 32 for supporting a reservoir of fluid, the receptacle having an inner surface (Para 374), (ii) a sensor 70+91+93 (Fig 10,11; Para 911 sets forth that “one or more (or all) of the extensions 700 of the cap is provided with one or more detectable elements 42 described above” and that “the infusion pump device 30 may include one or more corresponding sensor elements described above, arranged to detect the detectable elements 42”) provided in the receptacle, (iii) the cap 704 with the delivery tube 50 configured to removably mate with the receptacle (Para 899), and (iv) a pair of mating interlocking connectors comprising cap connectors 700,700 provided on the cap and receptacle connectors 32d,32d provided on the receptacle (Para 893), the cap connectors having a flexible arm (the portion of connector 700 from which 702 extends in Fig 44) and a finger 702 extending outwardly from the flexible arm (as seen in Fig 44), the flexible arm is urged inwardly when de-mating and mating the cap from the receptacle until a locked position is reached (Para 900,902); detecting a first force from the urged flexible arms with the sensor while the finger is engaged with the inner surface of the receptacle (Para 551; Para 911 sets forth that “one or more (or all) of the extensions 700 of the cap is provided with one or more detectable elements 42 described above” and that “the infusion pump device 30 may include one or more corresponding sensor elements described above, arranged to detect the detectable elements 42, for example, when extensions 700 are engaged with the ramp portion 32c, or when the extensions are engaged with the stop surface 32d, or when the extensions are flexed (or a combination thereof)”); and detecting a second force from the urged flexible arm with the sensor while the finger is engaged in the locked position (Para 551; Para 911 sets forth that “one or more (or all) of the extensions 700 of the cap is provided with one or more detectable elements 42 described above” and that “the infusion pump device 30 may include one or more corresponding sensor elements described above, arranged to detect the detectable elements 42, for example, when extensions 700 are engaged with the ramp portion 32c, or when the extensions are engaged with the stop surface 32d, or when the extensions are flexed (or a combination thereof)”). Although Pananen discloses recording in a memory 66 (Fig 5) the condition or state of the cap as a result of detected forces (Para 506), Pananen does not disclose recording the detected forces itself.
Engelhard, however, teaches providing a force sensor 446 (Fig 8, Para 136) on a first component 404 (Fig 9; wherein sensor 446 is a component of processor assembly 420 of Fig 9, Para 134; comparable to the receptacle of the housing of Pananen) that detects force from a second component 406 (Fig 9; comparable to the flexible arm of the cap of Pananen) when the force sensor is contacted by the second component (comparable to when the housing and the cap are mated/locked to each other in Pananen) and when the force sensor is no longer contacted by the second component (comparable to when the housing and the cap are de-mated/not locked to each other in Pananen) (Para 136) and recording the detected force in a memory (of processor 441, Para 134) since the recording of the detected force – as opposed to recording of just the result of the detected force, as in Pananen – helps to eliminate false positives (Para 137). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Pananen to record the detected forces themselves, as taught by Engelhard, for the purpose of aiding in eliminating false positives (Para 137).
Re claim 31, Pananen discloses that the sensor is a pressure sensor 70+91+93 (Fig 10,11) provided within a recess 32c (Fig 47) of the receptacle (Para 911 sets forth “the infusion pump device 30 may include one or more corresponding sensor elements described above, arranged to detect the detectable elements 42, for example, when extensions 700 are engaged with the ramp portion 32c”).
Re claim 32, Pananen discloses providing a detent 32d in the receptacle along the inner surface of the receptacle (as seen in Fig 47), the detent configured to receive the finger in interlocked engagement (Para 893).
Re claim 33, Pananen discloses that the pressure sensor is provided proximate the detent (Para 911 sets forth “the infusion pump device 30 may include one or more corresponding sensor elements described above, arranged to detect the detectable elements 42, for example, when extensions 700 are engaged with the ramp portion 32c”), and wherein detecting the first force from the urged flexible arm comprises detecting pressure of the urged flexible arm against the pressure sensor prior to the finger engaging within the detent (since the recess 32c precedes the detent 32d, as seen in Fig 47 and Para 897).
Re claim 34, Pananen discloses that the detecting the pressure comprises detecting pressure from the urged flexible arm against the inner surface of the recess (since the outer surface of the arm would directly contact the recess 32c when the finger 702 is in the detect 32d, as seen in Fig 45, member 70 of the sensor would be pushed by the outer surface of the arm, as seen in Fig 11), but does not disclose that detecting the pressure requires “measuring” the pressure. Engelhard, however, teaching that the detecting of the pressure comprises measuring pressure exerted from the second component against the first component (Para 136). As set forth in the rejection of claim 30 above, the first component is comparable to the receptacle of the housing of Pananen and the second component is comparable to the flexible arm of the cap of Pananen. The motivation set forth in the rejection of claim 30 also applies to this claim.
Re claim 35, Pananen discloses that the detected pressure of the urged flexible arm against the pressure sensor prior to the finger engaging within the detent indicates an unlocked state (since the recess 32c precedes the detent 32d, as seen in Fig 37 and Para 897).
Re claim 36, Pananen discloses that detecting the second force from the urged flexible arm comprises detecting pressure of the urged flexible arm against the pressure sensor when the finger engages with the detent indicating a locked state (Para 893).
Response to Arguments
Applicant's arguments filed 4/8/2026 have been fully considered but they are not persuasive. The arguments simply assert that Pananen and Engelhard do not disclose the features of the independent claims, but do not show how the amendments avoid the references. As set forth above, Pananen and Engelhard in combination teach the subject matter. Therefore, this argument is 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.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 It is noted that this suggested amendment also incorporates corrections to overcome the objection set forth above.
2 It is noted that this suggested amendment also incorporates corrections to overcome the objection set forth above.
3 A copy of this reference was provided with the 2/23/2026 Detailed Action.
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