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 Arguments
Applicant's arguments filed on August 6th, 2026, have been fully considered.
With regards to applicant’s argument under “Rejections Under- 35 U.S.C. §§ 102 and 103” on page 7 of Remarks, “Even if the drive transfer mechanism 2148 includes one or more drive shafts, there is no teaching or suggestion in Lane that these drive shafts (i) are separable from the motor 2142, or (ii) are even coupled to the motor 2142” for claim 1, have been fully considered but they are not persuasive. Examiner identifies the driver transfer mechanism 2148 and the motor 2142 collectively as the claimed driver. Lane discloses the drive transfer mechanism connected to the motor and further teaches that the drive shaft is separable from the drive transfer mechanism. Thus, Applicant’s argument that Lane does not expressly teach the drive shaft as separable from the motor does not establish that the claimed limitation is absent because the examiner maps the claimed driver as based on the combination of the motor and the drive mechanism, rather than the motor alone.
With regards to applicant’s argument under “Rejections Under- 35 U.S.C. §§ 102 and 103” on page 7 of Remarks, “Moreover, one of skill in the art would understand that the drive transfer mechanism 2148 is not separable from the motor 2142 because both are internal components of the drive assembly 2140. It would be difficult to open the drive assembly 2140 to access these internal components and separate them from each other. In addition, it does not appear from the disclosure of Lane that there would be no reason to separate these internal components of the drive assembly 2140.” for claim 1, have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the drive transfer mechanism 2148 is not separable from the motor 2142) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
With regards to applicant’s argument under “Rejections Under- 35 U.S.C. §§ 102 and 103” on page 7-8 of Remarks, “However, Lane again is completely silent as to a drive shaft itself that is able to be decoupled from and/or is completely removable from both the drive mechanism 2160 of the fluid delivery assembly 2130 and the drive transfer mechanism 2148 of the drive assembly 2140” for claim 1, have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a drive shaft itself that is able to be decoupled from and/or is completely removable from the drive mechanism 2160 of the fluid delivery assembly 2130) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Lane expressly discloses that the drive mechanism can include “one or more driveshafts”, this is interpreted as a removeable component of the driver, since the pump head can include a drive shaft that would be a removable component of the driver. Further, the rejection does not solely rely on Lane for the removeable drive shaft from the driver limitation. As set forth in the previous office action, the secondary reference, Cartledge, teaches a drive shaft provided as a removable component separated from a driver, and the examiner relies on this teaching in modifying Lane’s drive shaft, to be a removeable component separated from the driver as taught by Cartledge for reasons previously stated.
With regards to applicant’s argument under “Rejections Under- 35 U.S.C. §§ 102 and 103” on page 7-8 of Remarks, “one of skill in the art would understand that it would be difficult and unnecessary to separate the drive shaft of the drive transfer mechanism 2148 from the motor 2142 because (i) it would be difficult to access the interior of the drive assembly 2140 to do so, and (ii) there is no reason to separate the drive shaft of the drive transfer mechanism 2148 from the motor 2142.” for claim 1, have been fully considered but they are not persuasive. Lane’s schematic figure of the drive assembly does not establish the degree of difficulty associated with accessing or separating the depicted components. Further, the rejection relies on the combined teachings of Lane and Cartledge, which teaches a drive shaft provided as a removable component separated from the driver.
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.
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) 1 is rejected under 35 U.S.C. 102(a) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Lane et al. (WO 2022192285 A1, herein, Lane) in view of Cartledge et al. (US Pub No. 20080015507 A1, herein, Cartledge). For ease of discussion, the examiner will be referencing the foreign reference document (Lane), submitted by the applicant on 08/28/2025.
Regarding claim 1, Lane discloses an intravenous (IV) infusion set (2100 – Fig.24), comprising:
at least one infusion component (2120 – Fig.24);
a first IV tube coupled to the at least one infusion component (2133A – Fig.24);
a second IV tube (2133B – Fig.24); and
a pump head (2130 – Fig.24) that is disposable, the pump head comprising: an inlet port (“one-way check valves” – [00127]) coupled to the first IV tube (“via the fluid line” – Para [00127], Fig.24); an outlet port (“third check valve” – Para [00127]) coupled to the second IV tube (“between the first reservoir and the fluid line” – Para [00127]); and a drive interface (2160 – Fig. 24, “The pinion gear can define a drive shaft interface” – Para [00129]) configured to be coupled to a first end of a drive shaft (“a drive shaft of the drive transfer mechanism projects from a surface of the drive assembly and is configured to be engaged with a pinion of the drive mechanism” – Para [00132]),
wherein the drive interface is configured to be rotated by rotation of the drive shaft having a second end coupled to a driver (2148, 2142 – Fig.24) (“such that rotation of the drive shaft causes rotation of the pinion gear” – Para [00129]) to increase a fluid flow rate through the IV infusion set (“control fluid delivery of the fluid delivery assembly” – Para [00132]),
wherein the drive shaft (“a drive shaft of the drive transfer mechanism” – Para [00132]) is provided as a removable component separated from the driver (“the drive mechanism can include… one or more driveshafts” – Para [00129], the drive shaft is reasonably interpreted as a removeable component of the driver, since the pump head can include a drive shaft that would be a removable component of the driver) and as a removeable component separated from the pump head (2147, 2137 – Fig.24, “prevent accidental decoupling” - Para [00133]).
However, Lane does not explicitly disclose the drive shaft as a removeable component separated from the driver.
Cartledge teaches a drive shaft (305 – Fig.17) as a removeable component (“the roller head drive shaft can be designed so that it is removable” – Para [0086]) separated from a driver (300 – Fig.17).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the drive shaft of Lane, to be a removeable component separated from the driver as taught by Cartledge since Cartledge teaches that the drive shaft is designed to be removeable for replacement or service (Para [0086]).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Lane in view of Cartledge as applied in claim 1 above, and further in view of Causey, III et al. (US Pub No. 20100160861 A1, herein, Causey).
Regarding claim 6, Lane discloses the intravenous (IV) infusion set, as modified above, wherein the drive interface has a complementary shape (Para [00147]) but Lane does not expressly disclose wherein the drive interface is configured to receive the drive shaft comprising a hex shaped drive shaft.
Causey teaches wherein a drive interface (52- Fig.5) is configured to receive the drive shaft comprising a hex shaped drive shaft (50 – Fig.5) (“other shaped holes are used such as hexagonal… along with a drive shaft and a lead screw with mating ends that fit into the holes.” – Para [0069]).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the drive interface disclosed by Lane to be configured to receive the drive shaft comprising hex shaped drive shaft as taught by Causey since Causey teaches that it is well known that the hole of the drive interface, through which the drive shaft is attached, can be any shape, such as hex shaped, as so it can receive a hex shaped drive shaft (Para [0069]).
Regarding claim 7, Lane discloses the intravenous (IV) infusion set, as modified above, wherein the drive interface has a complementary shape (Para [00147]) but Lane does not expressly disclose wherein the drive interface is configured to receive the drive shaft comprising a star shaped drive shaft.
Causey teaches wherein a drive interface (52- Fig.5) is configured to receive the drive shaft comprising a star shaped drive shaft (“other shaped holes are used such as… star… along with a drive shaft and a lead screw with mating ends that fit into the holes.” – Para [0069]).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the drive interface disclosed by Lane to be configured to receive the drive shaft comprising a star shaped drive shaft as taught by Causey since Causey teaches that it is well known that the hole of the drive interface, through which the drive shaft is attached, can be any shape, such as star shaped, as so it can receive a star shaped drive shaft (Para [0069]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Lane in view of Cartledge as applied in claim 1 above, and further in view of Spohn et al. (US Pub No. 20140350521 A1, herein, Spohn).
Regarding claim 8, Lane discloses the intravenous (IV) infusion set, as modified above, wherein a luer lock connector is configured to be coupled to a catheter inserted into a patient (“The fluid line can be fluidically coupled to a patient (e.g., a patient’s vasculature) via, for example, a luer lock connector” – para [00136]).
However, Lane does not expressly disclose wherein the at least one infusion component comprises: a fluid connector configured to be coupled to a fluid container.
Spohn teaches wherein at least one infusion component comprises: a fluid connector (976a – Fig.7G) configured to be coupled to a fluid container (890 – Fig.7G) (“spikes… are used to connect… saline source” – Para [0143]).
Therefore, it would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the infusion component as disclosed by Lane to comprise a fluid connector configured to be coupled to a fluid container as taught by Spohn for purposes of connecting a catheter to a saline source (Spohn, Para [0143]).
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 Marissa Taylor whose telephone number is (571)272-3542. The examiner can normally be reached Monday-Thursday 6:30am-3:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARISSA TAYLOR/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
