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
Claims 8-15 and 35-37 are objected to because of the following informalities:
Claim 8 recites “a infusion pump” in line 2, which should be amended to “[[a]]an infusion pump” for grammar.
Dependent claims inherit the deficiencies of the claims from which they depend.
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.
Claims 9, 10 and 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 9 recites the limitation "the second septum" in two instances. There is insufficient antecedent basis for this limitation in the claim. It will be assumed that “a septum” introduced in line 2 was intended to recite “a second septum”.
Claim 36 recites “movement of the inserter needle towards the deployed configuration is configured to unlock the second lock to release the device.” Firstly, this appears inconsistent with claim 35, as claim 35 states that the first lock is what connects the device to the cannula inserter. Secondly, since claim 35 requires that the second lock is configured to restrain an inserter needle in an undeployed configuration, it is unclear how movement of the inserter needle would even occur prior to the second lock being unlocked.
Dependent claims inherit the deficiencies of the claims from which they depend.
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 of this title, 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, 4-11 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ethelfeld (US 2006/0095014 A1, cited previously) in view of Wojcik (US 2007/0191772 A1).
As to claim 1, Ethelfeld discloses a method of deploying an infusion pump, the method comprising:
positioning an infusion pump (any of 250, 350, 450, 550, 650, 850; see para 0009, 0084-0087, 0093, 0094, Figs. 1-13C) including a cannula (260, 360, etc…) and retained in a cannula inserter (210, 310, etc…) adjacent to a surface (each embodiment placed on skin before activation); and
actuating the cannula inserter to deploy the cannula into the surface and release the infusion pump from the cannula inserter (see Figs. 5-9, 13A-13C and para 0035, 0064-0077, 0092).
Ethelfeld is silent to wherein actuating the cannula inserter deploys the cannula through a septum of the infusion pump.
Wojcik discloses an infusion set including a septum (18, 118; see para 0038, 0057, Figs. 3-6, 9, 12-15).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a septum in a bottom wall of the infusion pump of Ethelfeld, such that actuating the cannula inserter deploys the cannula through the septum of the infusion pump. One would have been motivated to do so to provide a seal around the outside of the cannula after insertion (see para 0038, 0057 of Wojcik).
As to claim 4, Ethelfeld in view of Wojcik teaches the method of claim 1, and Ethelfeld further discloses wherein actuating the cannula inserter includes camming a first lock (see annotated Fig. 13A below) out of engagement with a needle inserter (840) to permit the needle inserter to move from an undeployed configuration (configuration in Fig. 13A) to a deployed configuration (configuration in Fig. 13B) to deploy the cannula (Figs. 13A-13C, para 0092).
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As to claim 5, Ethelfeld in view of Wojcik teaches the method of claim 4 as described above, and Ethelfeld further discloses sealing a portion of a chamber (interior of the cannula) the infusion pump with a septum connected to the cannula as the cannula is deployed (see para 0092).
As to claim 6, Ethelfeld in view of Wojcik discloses the method of claim 1 as described above, further comprising retracting a needle (880) from the cannula and the infusion pump while retaining the cannula on the infusion pump (see Fig. 13C, para 0092 of Ethelfeld).
As to claim 7, Ethelfeld in view of Wojcik teaches the method of claim 1 as described above, wherein deploying the cannula includes deploying an inserter needle (880) the cannula is disposed on (Figs. 13A-13C, para 0092 of Ethelfeld).
As to claim 8, Ethelfeld discloses a system comprising:
a infusion pump (any of 250, 350, 450, 550, 650, 850; see para 0009, 0084-0087, 0093, 0094, Figs. 1-13C) including a cannula (260, 360, etc…); and
a cannula inserter (210, 310, etc…), wherein the infusion pump is initially connected to the cannula inserter, and wherein the cannula inserter is configured to retain the infusion pump prior to actuation, and deploy the cannula of the infusion pump and release the infusion pump during actuation (see Figs. 5-9, 13A-13C and para 0035, 0064-0077, 0092).
Ethelfeld is silent to wherein the cannula inserter deploys the cannula of the infusion pump through a first septum of the infusion pump.
Wojcik discloses an infusion set including a septum (18, 118; see para 0038, 0057, Figs. 3-6, 9, 12-15).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a septum in a bottom wall of the infusion pump of Ethelfeld, such that actuating the cannula inserter deploys the cannula through the septum of the infusion pump. One would have been motivated to do so to provide a seal around the outside of the cannula after insertion (see para 0038, 0057 of Wojcik).
As to claim 9, Ethelfeld in view of Wojcik teaches the system of claim 8 as described above, and Ethelfield further discloses wherein the infusion pump further comprises a [second] septum (861), wherein the cannula is connected to and extends from the second septum (see Fig. 13A), and wherein the second septum is configured to seal at least a portion of a chamber (interior of the cannula) of the infusion pump when the cannula is in a deployed configuration (see Figs. 13A-13C, para 0092).
As to claim 10, Ethelfeld in view of Wojcik teaches the system of claim 9 as described above, and Ethelfield further discloses wherein movement of an inserter needle towards the deployed configuration releases the infusion pump from the cannula inserter (see Figs. 13A-13C, para 0092).
As to claim 11, Ethelfeld in view of Wojcik teaches the system of 8 as described above, and Ethelfeld further discloses wherein the cannula inserter (for the purposes of rejecting claim 11, cannula inserter interpreted as 810; see Figs. 13A-13C) comprising:
an inserter needle (808) configured to move between an undeployed configuration (configuration in Fig. 13A) and a deployed configuration (configuration in Fig. 13B);
a second lock (see annotated Fig. 13A below) configured to selectively restrain the inserter needle in the undeployed configuration; and
a trigger (820 and/or 830; see similar actuation members 120, 130 of Figs. 2A-5 and described in para 0060), wherein actuation of the trigger is configured to unlock the first lock to permit the inserter needle (808) to move from the undeployed configuration to the deployed configuration and to unlock the second lock to release the infusion pump (see Figs. 2A-5, 13A-13C, and para 0092).
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The embodiment of Figs. 13A-13C additionally shows a device (850) including a cannula (860), however, the embodiment of Figs. 13A-13C is not shown with a first lock configured to selectively connect the infusion pump to the cannula inserter. However, the embodiment of Ethelfeld seen in Fig. 6B teaches a first lock (245, 246), wherein the first lock is configured to selectively connect the device (250’) to the cannula inserter (210’).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the embodiment of Figs. 13A-13C of Ethelfeld, to incorporate the first lock as disclosed in Fig. 6B. One would have been motivated to do so as a way to make the inserter releasably attachable to the device (see para 0067 of Ethelfeld).
As to claim 35, Ethelfield in view of Wojcik teaches the system of claim 8 as described above, and Ethelfeld further discloses, in the embodiment of Figs. 13A-13C, a second lock (see annotated Fig. 13A below), wherein the second lock is configured to restrain an inserter needle (880) in an undeployed configuration (configuration in Fig. 13A).
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The embodiment in Figs. 13A-13C is not shown with a first lock, wherein the first lock is configured to initially connect the infusion pump to the cannula inserter. However, the embodiment of Ethelfeld seen in Fig. 6B teaches a first lock (245, 246), wherein the first lock is configured to initially connect the device (250’) to the cannula inserter (210’).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the embodiment of Figs. 13A-13C of Ethelfield, to incorporate the first lock as disclosed in Fig. 6B. One would have been motivated to do so as a way to make the inserter releasably attachable to the device (see para 0067).
Claim(s) 1, 2, 3, 8-15, 35 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 2013/0138078 A1), cited previously and hereafter “Smith” in view of Wojcik.
As to claim 1, Smith discloses a method of deploying an infusion pump (see Figs 1A, 3-8, 10-10B; para 0041, 0065-0078 – see flowchart in Fig 8 which shows a method of deploying an infusion pump 10 apparatus as shown in Fig 1A), the method comprising:
positioning an infusion pump including a cannula and retained in a cannula inserter adjacent to a surface (see Figs 4-4A-8; para 0065, 0072, 0073 - see cartridge 100 and cannula assembly 650 which comprises a cannula 600 and is positioned inside a cannula inserter 800 as seen in Figs 6A-B wherein the entire setup is placed against the skin of the user); and
actuating the cannula inserter to deploy the cannula into the surface and release the infusion pump from the cannula inserter (see Figs 6A-8, 10A-B; para 0066-0068, 0073-0078 - see cannula inserter 800 having an actuator in the form of a collar 830 which when rotated releases the locked cannula assembly 650 and the trocar 860 pierces the septum 656 of cannula assembly 650 and further the cannula 600 is deployed in the tissue of the patient and the cannula inserter is released or disengaged from the cannula assembly (see step S119 in Fig 8)).
Smith is silent to wherein actuating the cannula inserter deploys the cannula through a septum of the infusion pump.
Wojcik discloses an infusion set including a septum (18, 118; see para 0038, 0057, Figs. 3-6, 9, 12-15).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a septum in a bottom wall of the infusion pump of Wojcik, such that actuating the cannula inserter deploys the cannula through the septum of the infusion pump. One would have been motivated to do so to provide a seal around the outside of the cannula after insertion (see para 0038, 0057 of Wojcik).
As to claim 2, Smith in view of Wojcik discloses the method of claim 1 as described above, and Smith further discloses wherein releasing the infusion pump includes deforming two latches (822) out of engagement with a corresponding portion of the infusion pump (see Figs 1, 3-6B; para 0064-0067, 0078 - see movement of the trocar further causes the pivotable locking features 822 to disengage with the features 853 by deforming their shape allowing the cannula assembly 650 to be released from the inserter main body 820 to deploy the cannula 600).
As to claim 3, Smith in view of Wojcik discloses the method of claim 2 as described above, and Smith further discloses wherein deforming the two latches (822) includes deforming the two latches against a portion (850) of a needle inserter (875) as the needle inserter moves between an undeployed configuration and a deployed configuration to deploy the cannula (para 0074 of Smith).
As to claim 8, Smith discloses a system (see Figs 1A, 3-7A, 10-10B; para 0041, 0065-0078 - see system to deploying a cannula 600 of an infusion pump apparatus 10 as shown in Fig 1A) comprising:
a infusion pump (650, Figs 4-4A; para 0065 - see cannula assembly 650) including a cannula (600, Fig 4-4A; para 0065 - see cannula 600 which is a part of the cannula assembly 650); and
a cannula inserter (800, Figs 1A, 3, 5, 6A-B; para 0066), wherein the infusion pump is initially connected to the cannula inserter, and wherein the cannula inserter is configured to retain the infusion pump prior to actuation (see Figs 6A-B; para 0067 - see cannula assembly 650 having the cannula 600 attached to the inserter 800 and wherein the inserter 800 holds the cannula assembly in a pre-firing state as seen in Figs 6AB in which the cannula 600 .is not deployed), and deploy the cannula of the infusion pump and release the infusion pump during actuation (see Figs 6A-8, 10A-B; para 0066-0068, 0073-0078 - see inserter 800 which when actuated by rotating collar 830 causes the cannula 600 to deploy and the inserter is released from the cannula assembly 650 upon actuation of the collar 830 (see S119 in Fig 8)).
Smith is silent to wherein the cannula inserter deploys the cannula of the infusion pump through a first septum of the infusion pump.
Wojcik discloses an infusion set including a septum (18, 118; see para 0038, 0057, Figs. 3-6, 9, 12-15).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a septum in a bottom wall of the infusion pump of Smith, such that actuating the cannula inserter deploys the cannula through the septum of the infusion pump. One would have been motivated to do so to provide a seal around the outside of the cannula after insertion (see para 0038, 0057 of Wojcik).
As to claim 9, Smith in view of Wojcik discloses the system of claim 8 as described above, and Smith further discloses wherein the infusion pump further comprises a septum (656, Fig 4-4A; para 0065), wherein the cannula is connected to and extends from the second septum, and wherein the second septum is configured to seal at least a portion of a chamber of the infusion pump when the cannula is in a deployed configuration (see Figs 4-4A, 6A-B, 10A-B; para 0065, 0073-0078 - see cannula 600 which extends from the septum 656 and the portion of the septum after being pierced by the trocar 860 in a deployed configuration is capable of seal a partial portion of the hollow volume of the cannula assembly body).
As to claim 10, Smith in view of Wojcik discloses the system of claim 9 as described above, and Smith further discloses wherein movement of an inserter needle towards the deployed configuration releases the infusion pump from the cannula inserter (see Figs 1, 3-6B; para 0064-0067, 0078 - see movement of the trocar 860 further causes the pivotable locking features 822 to disengage with the features 853 allowing the cannula assembly 650 to be released from the inserter main body 820 to deploy the cannula 600).
As to claim 11, Smith in view of Wojcik teaches the system of claim 8 as described above, and Smith further discloses wherein the cannula inserter comprises:
a first lock (see Figs 5-6B; para 0066-0067, 0074 - see locking features 822) configured to selectively connect the infusion pump to the cannula inserter (see Figs 1, 3-6B; para 0064-0067, 0078 - see locking features 822 engage with complementary locking features 853 on spring retainer 850 wherein the spring retainer 850 and trocar hub 840 (combined slide assembly 875) along with cannula assembly 650 forms the device to which the cannula 600 is attached);
an inserter needle configured to move between an undeployed configuration and a deployed configuration (860, Figs 6-7A, 10-10B; para 0068, 0075, 0077 - see trocar 860 which moves from a undeployed configuration in Figs 6A-B to a deployed configuration in Figs 10A-B when actuated);
a second lock configured to selectively restrain the inserter needle in the undeployed configuration (see Figs 5C-7A; para 0066·0068, 0077 - see trocar locking features 844 and 854 which engage each other until actuated to hold the trocar 860 in place in an undeployed configuration as seen in Figs 6A-B); and
a trigger, wherein actuation of the trigger is configured to unlock the first lock to permit the inserter needle to move from the undeployed configuration to the deployed configuration and to unlock the second lock to release the infusion pump (see Fig 5, 5B, 6A-B, 8, 10A-B; para 0066-0068, 0073-0078 - see actuator 830 which when rotated locking features 822 and 853 to disengage and allow main spring 810 to move and deploy cannula 600 along with the trocar 860 further the trocar locking features 844 and 854 disengage thereby moving the trocar back and further disengaging the trocar slider assembly 875 from the main body 820 of the inserter).
As to claim 12, Smith in view of Wojcik teaches the system of claim 11, wherein movement-of the inserter needle from the undeployed configuration to the deployed configuration unlocks the second lock (see Fig 5, 5B, 6A-B, 8, 10A-B; para 0066-0068, 0073-0078 of Smith - see movement of the trocar needle 860 as the slider assembly 875 after crossing the locking surface 827 causes the locking features 844 and 854 to disengage).
As to claim 13, Smith in view of Wojcik teaches the system of claim 11, wherein the first lock comprises two opposing arms configured to engage a corresponding portion of the infusion pump to selectively connect the infusion pump to the cannula inserter (see Figs 1, 3-6B; para 00640067, 0078 of Smith - see locking features 822 engage with a complementary locking features 853).
As to claim 14, Smith in view of Wojcik teaches the system of claim 13, wherein movement of the inserter needle from the undeployed configuration to the deployed configuration deforms the two opposing arms out of engagement with the corresponding portion of the infusion pump to release the device (see Figs 1, 3-6B; para 0064-0067, 0078 of Smith - see movement of the trocar further causes the pivotable locking features 822 to disengage with the features 853 by deforming their shape allowing the cannula assembly 650 to be released from the inserter main body 820 to deploy the cannula 600).
As to claim 15, Smith in view of Wojcik teaches the system of claim 11, further comprising a third lock configured to retain the cannula in the deployed configuration and connected to the infusion pump (see para 0081 of Smith teaching multiple different forms of locks that prevent cannula 600 from withdrawing from patient).
As to claim 35, Smith in view of Wojcik teaches the system of claim 8, and Smith further discloses a first lock (see Figs 5-6B; para 0066-0067, 0074 - see locking features 822) and a second lock (see Figs 5C-7A; para 0066·0068, 0077 - see trocar locking features 844 and 854 which engage each other until actuated to hold the trocar 860 in place in an undeployed configuration as seen in Figs 6A-B), wherein the first lock is configured to initially connect the infusion pump to the cannula inserter (see Figs 1, 3-6B; para 0064-0067, 0078 - see locking features 822 engage with complementary locking features 853 on spring retainer 850 wherein the spring retainer 850 and trocar hub 840 (combined slide assembly 875) along with cannula assembly 650 forms the device to which the cannula 600 is attached), and the second lock is configured to restrain an inserter needle in an undeployed configuration (see Figs 5C-7A; para 0066·0068, 0077 - see trocar locking features 844 and 854 which engage each other until actuated to hold the trocar 860 in place in an undeployed configuration as seen in Figs 6A-B).
As to claim 37, Smith in view of Wojcik teaches the system of claim 8, and Smith further discloses a third lock configured to retain the cannula in the deployed configuration and connected to the infusion pump (see para 0081 teaching multiple different forms of locks that prevent cannula 600 from withdrawing from patient).
Claim(s) 15 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ethelfeld in view of Wojcik as applied above, and further in view of Carter et al. (US 2007/0282269 A1, cited previously and hereafter “Carter”).
As to claim 15, Ethelfeld in view of Wojcik makes obvious the limitations of claim 11 as described above, but is silent to a third lock configured to retain the cannula in the deployed configuration and connected to the infusion pump.
Carter discloses a lock (212+236) configured to retain a cannula (224) in the deployed configuration and connected to the device (210) (see Figs. 13-16, para 0068-0069).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Ethelfeld (as already modified above) by including a third lock configured to retain the cannula in the deployed configuration and connected to the infusion pump. One would have been motivated to do so to ensure the cannula remains in the patient (see Figs. 13-16, para 0068-0069 of Carter).
As to claim 37, Ethelfeld in view of Wojcik teaches the system of claim 8 as described above, but is silent to a third lock configured to retain the cannula in the deployed configuration and connected to the infusion pump.
Carter discloses a lock (212+236) configured to retain a cannula (224) in the deployed configuration and connected to the device (210) (see Figs. 13-16, para 0068-0069).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Ethelfeld by including a third lock configured to retain the cannula in the deployed configuration and connected to the infusion pump. One would have been motivated to do so to ensure the cannula remains in the patient (see Figs. 13-16, para 0068-0069 of Carter).
Allowable Subject Matter
No claims are currently allowed.
The examiner notes that no prior art rejection has been given for claim 36. However, the lack of clarity around this claim has prevented the claim from being considered allowable.
Response to Arguments
Applicant’s Remarks submitted 2/2/26 have been considered.
Regarding the previous Drawing Objections, the Remarks are persuasive and the previous objections have been withdrawn.
Regarding the previous Claim Objections, the Remarks are moot/persuasive as the amendments have obviated the previous objection.
Regarding the previous rejections under 35 U.S.C. § 112, the Remarks are persuasive. However, the examiner notes that the Remarks did not specifically address the rejection of claim 36, and the amendments did not obviate the previously-noted clarity issues. Therefore the rejection of claim 36 is maintained.
Regarding the previous rejections under 35 U.S.C. § 102 and § 103, the arguments are moot as the amendments have prompted use of the secondary reference (Wojcik) to now reject the claims as noted above.
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 James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/James D Ponton/Primary Examiner, Art Unit 3783
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