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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/20/26 has been entered.
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 1-15 and 35-37 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, as amended, recites “actuating the cannula inserter to deploy the cannula through a septum that seals a chamber of the infusion pump in fluid communication with one or more reservoirs of the infusion pump”. This wording is unclear for multiple reasons. Firstly, it is contradictory to say that the chamber is sealed but also in fluid communication with one or more reservoirs. The examiner believes that at best, the claimed septum might only be sealing a single portion/end of the chamber - which is further believed to be accurate based the wording in claim 5 which states “sealing a second portion of the chamber of the infusion pump with a second septum…”. Secondly, the wording is ambiguous as to whether the actuating is something that actively causes the septum to seal the chamber in fluid communication with one or more reservoirs, or if the septum is already sealing the chamber in fluid communication with the one or more reservoirs prior to the actuating. The examiner also notes that the claimed chamber does not appear to have a corresponding reference numeral and does not appear to be pointed out in the drawings, making it further difficult to ascertain the scope of the scope.
Claims 2-7 are rejected as they depend from a rejected claim.
Claim 8, as amended, recites “to deploy the cannula of the infusion pump through a first septum that seals a chamber of the infusion pump in fluid communication with one or more reservoirs”. This wording is unclear for multiple reasons. Firstly, it is contradictory to say that the chamber is sealed but also in fluid communication with one or more reservoirs. The examiner believes that at best, the claimed septum might only be sealing a single portion/end of the chamber - which is further believed to be accurate based the wording in claim 5 which states “sealing a second portion of the chamber of the infusion pump with a second septum…” (also see similar wording in claim 9). Secondly, the wording is ambiguous as to whether the deploying is something that actively causes the septum to seal the chamber in fluid communication with one or more reservoirs, or if the septum is already sealing the chamber in fluid communication with the one or more reservoirs prior to the deploying. The examiner also notes that the claimed chamber does not appear to have a corresponding reference numeral and does not appear to be pointed out in the drawings, making it further difficult to ascertain the scope of the scope.
Claim 9 recites “…a second septum, 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”. This is now unclear with the amendments to claim 8, which introduce “a first septum that seals a chamber of the infusion pump in fluid communication with one or more reservoirs”. In other words, it is not clear if claim 9 is intended to refer to the same chamber as claim 8 or a different chamber.
Claim 12, as amended, contradicts claim 11. Claim 11 recites “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”, however claim 12 recites “wherein movement of the inserter needle from the undeployed configuration to the deployed configuration unlocks the first lock”.
Claims 9-15 and 35-37 are rejected as they depend from a rejected claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 6-8, 35 and 37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carter et al. (US 2007/0282269 A1, cited previously and hereafter “Carter”).
As to claim 1, Carter discloses a method of deploying an infusion pump, the method comprising:
positioning an infusion pump (500; see Figs. 21-24) including a cannula (224) and retained in a cannula inserter (600) adjacent to a surface (surface of skin 140); and
actuating the cannula inserter to deploy the cannula through a septum (502) that seals a chamber (small chamber immediately above 502; annotated below) of the infusion pump in fluid communication with one or more reservoirs (bigger chamber where needle/cannula rest as seen in Fig. 22) of the infusion pump (see annotated Fig. 22 below) into the surface and release the infusion pump from the cannula inserter (see transition from Figs. 22-24; paragraphs 0084-0086).
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As to claim 6, Carter discloses the method of claim 1, further comprising retracting a needle (234) from the cannula and the infusion pump while retaining the cannula on the infusion pump (Fig. 24, para 0085-0086).
As to claim 7, Carter discloses the method of claim 1, wherein deploying the cannula includes deploying an inserter needle (234) the cannula is disposed on (see Figs. 22-23, para 0067).
As to claim 8, Carter discloses a system comprising:
an infusion pump (500; see Figs. 21-24) including a cannula (224); and
a cannula inserter (600), wherein the infusion pump is initially connected to the cannula inserter (see Fig. 22), and wherein the cannula inserter is configured to retain the infusion pump prior to actuation (Fig. 22, para 0080), and to deploy the cannula of the infusion pump through a first septum (502) that seals a chamber (small chamber immediately above 502; annotated above) of the infusion pump in fluid communication with one or more reservoirs (annotated above) and release the infusion pump during actuation (see transition from Figs. 22-24; paragraphs 0084-0086).
As to claim 35, Carter discloses the system of claim 8, further comprising a first lock (not numbered, however Carter teaches “The spring 662 may be released by depressing a pair of aligned actuator buttons on opposite sides of the driver 600. One such actuator button 670 is shown in FIG. 22. Preferably the actuator buttons are only coupled to release the springs 662 and 666 when the driver 600 is detachably received on the infusion device 500. Hence, in this manner, the driver is enabled only when the driver is properly positioned and locked for the purpose of deploying the cannula 224” – para 0083) and a second lock (602, 514), wherein the first lock is configured restrain an inserter needle in an undeployed configuration (see para 0083), and the second lock is configured to initially connect the infusion pump to the cannula inserter (para 0080).
As to claim 37, Carter discloses the system of claim 8, further comprising a third lock (latch 212 + flange 236) configured to retain the cannula in the deployed configuration and connected to the infusion pump (see para 0066; also see para 0081 teaching “The cannula driver 600 of FIGS. 22-24 utilizes, for example, the cannula assembly 230 of FIGS. 13-16”).
Allowable Subject Matter
Claims 2-5, 9-15, and 36 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Each of the specified claims requires subject matter that is not taught by Carter in combination with the limitations of each claim(s) they respectively depend from. For example, with regard to claim 2, while Carter teaches the method of claim 1 as described above, Carter is silent to wherein releasing the infusion pump includes deforming two latches out of engagement with a corresponding portion of the infusion pump in combination with the limitations of claim 1.
The examiner does note, however, that amendments to address the above rejections under 35 U.S.C. 112(b) may affect the allowability of the claims.
Response to Arguments
Applicant’s Remarks submitted 7/20/26 have been considered.
With regard to the arguments concerning the previous Claim Objections (page 6 of Remarks) and rejections under 35 U.S.C. 112 (pages 7-8 of Remarks), the amendments have obviated the previous objections. However, the amendments have also resulted in new rejections as noted above.
With regard to the arguments concerning the previous rejections under 35 U.S.C. 103 (pages 8-19 of Remarks), while not agreeing with all of the Remarks, the amendments to the claims have obviated the previous rejections. However, the amendments have also resulted in new rejections above using the Carter reference. The examiner does not that the applicant points out on page 10 of the Remarks that “During operation of the infusion pump to deliver a therapeutic compound to the tissue of a subject, there is a clear path from the microfluidic laminates, through the distributor, through the side-port on the cannula, and into the tissue through a distal end of the cannula deployed into the subject's tissue”. The examiner recommends amending the independent claim(s) to use language similar to this. The examiner also recommends amending the claim to clarify the structure of the chamber, perhaps by introducing the chamber on its own line and/or clarifying when/how the chamber is sealed.
Conclusion
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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