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 .
Response to Amendment
The amendment filed on 8/8/2025 has been entered. Claims 1-3 and 5-16 are pending in the application. Claim 4 is cancelled. Claims 7-9 and 13-14 are withdrawn. The amendments to the claims, drawings, and specification overcome each and every objection previously set forth in the Non-Final Office Action mailed on 5/8/2025.
Claim Objections
Claim 6 is objected to because of the following informalities:
-Claim 6, line 2: please correct “the conductive strip” to “the at least one conductive strip”
-Claim 6, lines 3-4: please correct “the drop off” to “the drop-off”
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-2, 5, 10-12, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Archibald (US 4,277,226 A) in view of Govari et al. (US 2018/0014878 A1).
Regarding claim 1, Archibald discloses a fluid pump system for a wearable fluid delivery device (Fig. 1, pump 10), comprising:
a control system (Fig. 1, pump control 58);
a first pump element (Fig. 1, cam follower rod 72) comprising a piston (Fig. 1, piston 46 is attached to cam follower rod 72) associated with a first electrical element (Fig. 1, flexible contact 86); and
a second pump element (Fig. 1, cam 64) associated with a second electrical element (Fig. 1, col. 4 lines 63-68, col. 5 lines 1-3, spring contact 84 is connected to ground, spring contact 84 is also connected to metallic cam shaft 60 which is attached to cam 64);
wherein the first pump element (Fig. 1, cam follower rod 72) is configured to engage the second pump element (Fig. 1, cam 64) to form an electrical circuit between the first electrical element (Fig. 1, flexible contact 86) and the second electrical element (col. 4 lines 63-68, col. 5 lines 1-8), the control system (Fig. 1, pump control 58) configured to receive at least one signal from the electrical circuit (col. 5 lines 9-18).
However, Archibald fails to state the second pump element comprising a snail cam having a ramp and drop-off.
Govari teaches a fluid pump system (Fig. 1, par. [0047], pump 20), comprising a snail cam (Fig. 2A, snail cam 24) having a ramp (Fig. 2B, par. [0049], the radius of snail cam 24 increases in a counterclockwise direction until the apex of tooth 34) and a drop-off (Fig. 2B, tooth 34) (Fig. 2B, par. [0055], snail cam 24 controls piston 26 via peg 28).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid pump system of Archibald to include that the cam has a "snail" shape, as taught by Govari, in order to create the effect of a rapid reversal in the direction of movement of the piston (see Govari par. [0049]).
Regarding claim 2, modified Archibald teaches the fluid pump system of claim 1 substantially as claimed. Archibald further teaches the first electrical element and the second electrical element comprising at least one conductive material (col. 4 lines 63-68, col. 5 lines 1-8).
Regarding claim 5, modified Archibald teaches the fluid pump system of claim 1 substantially as claimed. Modified Archibald further teaches the first electrical element (Archibald, Fig. 1, flexible contact 86) comprising at least one projection (Archibald, Fig. 1, flexible contact 86 projects) extending from a portion of the piston (Archibald, Fig. 1, piston 46 is attached to cam follower rod 72) engaging the ramp (Govari, Fig. 2B, par. [0049], the radius of snail cam 24 increases in a counterclockwise direction until the apex of tooth 34) of the snail cam (Govari, Fig. 2A, snail cam 24) (see Archibald Fig. 1, see previous modifications in rejection of claim 1 above to modify the cam 64 of Archibald to be a snail cam as taught by Govari).
Regarding claim 10, modified Archibald teaches the fluid pump system of claim 5 substantially as claimed. Modified Archibald further teaches wherein the at least one signal comprises a resistance value configured to indicate a position of the piston on the ramp of the snail cam (Archibald, col. 5 lines 9-18, see previous modifications in rejection of claim 1 above to modify the cam 64 of Archibald to be a snail cam as taught by Govari).
Regarding claim 11, modified Archibald teaches the fluid pump system of claim 5 substantially as claimed. Modified Archibald further teaches wherein the control system is configured to determine pump information based on the at least one signal (Archibald, col. 4 lines 63-68, col. 5 lines 1-18, see previous modifications in rejection of claim 1 above to modify the cam 64 of Archibald to be a snail cam as taught by Govari).
Regarding claim 12, modified Archibald teaches the fluid pump system of claim 11 substantially as claimed. Modified Archibald further teaches wherein the control system is configured to change a fluid path of the fluid pump system based on the at least one signal (Archibald, col. 5 lines 19-33, col. 6 lines 1-7, see previous modifications in rejection of claim 1 above to modify the cam 64 of Archibald to be a snail cam as taught by Govari).
Regarding claim 15, modified Archibald teaches the fluid pump system of claim 1 substantially as claimed. Archibald further teaches a reservoir configured to store a fluid (Fig. 1, bag 12); and a needle configured to infuse the fluid into a patient (Fig. 1, col. 3 lines 15-20, outlet tubing 22 is connected to outlet 24 of pump 10, and terminates at a needle (not shown) which is inserted into the patient).
Regarding claim 16, modified Archibald teaches the fluid pump system of claim 15 substantially as claimed. Archibald further teaches wherein the fluid is insulin (because the "fluid" is only functionally recited in claim 15, Archibald only needs to meet the requirement that the reservoir is structurally capable of storing insulin and the needle is only structurally capable of infusing insulin into a patient; both functional requirements are met by the structure of bag 12 and the "needle" of col. 3 lines 15- 20).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Archibald (US 4,277,226 A) in view of Govari et al. (US 2018/0014878 A1), as applied to claim 1 above, further in view of Ramey (US 2003/0009133 A1).
Regarding claim 3, modified Archibald teaches the fluid pump system of claim 1 substantially as claimed. However, modified Archibald fails to teach wherein the wearable fluid delivery device comprises an insulin infusion device.
However, Ramey teaches a fluid pump device (Fig. 1, par. [0041], a portable pump system for use in an ambulatory injection system) in the form of an insulin infusion device (par. [0041]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid pump system of modified Archibald to replace the fluid being pumped with insulin, as taught by Ramey, in order to treat a diabetic person (see Ramey par. [0041]).
Allowable Subject Matter
Claim 6 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 6 was previously indicated as allowable in the Non-Final Office Action mailed on 5/8/2025 and remains allowable for the same reasons indicated in said Office Action. Please see said Office Action for a detailed statement of reasons for allowability of claim 6.
Response to Arguments
Applicant's arguments filed 8/8/2025 have been fully considered but they are not persuasive.
In regards to independent claim 1, Applicant argues that Govari is in a different field of endeavor and does not consider placing a snail cam in a wearable device because Govari’s fluid pump system is large and stationary. This argument is not found to be persuasive. Archibald and Govari are both concerned with structures of fluid pump systems for medical purposes. Cams are well known structures found in fluid pumps of many different sizes. There is no evidence found in either reference or widely known in the art that would suggest that the snail cam of Govari could not be appropriately scaled into the device of Archibald. Therefore, the Examiner maintains that the modification in the rejection of claim 1 above is appropriate and would be obvious for the reasons described in the rejection.
Conclusion
THIS ACTION IS MADE FINAL. 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 AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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