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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/26/2025 has been entered.
Claim Objections
Claim 2 objected to because of the following informalities: Claim 2 recites “wherein and” in lines 1-2, but instead should omit “and”. 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.
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.
Claims 1-6, 21-24, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Bullington et al. (US 20150246352 A1-Previosuly cited), referred to as Bullington hereinafter, further in view of Schmitt (US 5086780- Previously cited).
Regarding claims 1 and 21, Bullington teaches an apparatus comprising: a housing (see fig. 10, transfer adapter 320) having a proximal end portion (323) and a distal end portion (321) and defining an inner volume;
a proximal coupler (324) coupled to the proximal end portion of the housing and configured to be fluidically coupled to a fluid collection device (300) (see para. [0102], “port 324 can be in fluid communication with the puncture member 350”);
a distal coupler (311) being coupleable to the distal end portion of the housing (see fig. 12, 321), the distal coupler configured to be coupled to an access device configured to be in fluid communication with a patient; (see para. [0002,0064,0110] and fig. 12, bodily fluid flows through the distal coupler 311;see para. [0102,0110-111], “can be physically and fluidically coupled to a peripheral intravenous (IV) needle and/or the like, as described with reference to the port 224” and “proximal end portion 351 of the puncture member 350 is placed in contact with the port 313 (e.g., pierces the port 313) included in and/or defined by the surface 312,”, “with the fluid flow path defined between the flow of bodily-fluid in the patient and the lumen defined by the puncture member 350 (e.g., via the lumen defining device and the port 324, as described above), the puncture member 350 can place the fluid reservoir 310 in fluid communication with the flow of bodily-fluid in the patient” indicating that access device coupled to member (324) is placed in contact with distal coupler (311) via its surface (312));
a fluid communicator (350 puncture member) disposed in the inner volume of the housing (320);
a stage (490) disposed in the housing (320) and moveable between a first position and a second position (see figs. 7-12);
and a lock (331-333) coupled to the housing, the lock in a first configuration (see fig. 12) being configured to engage the distal coupler to couple the distal coupler to the housing such that a portion of the fluid communicator extends through a seal (313) of the distal coupler to establish fluid communication between the distal coupler and the proximal end portion of the housing and to allow bodily fluid to flow from the distal coupler through the proximal end potion of the housing and into the fluid collection device (300) (see para. [0110], “pierce the port 313 of the fluid reservoir 310 such that a portion of the puncture member 350 is disposed in an inner volume defined by the fluid reservoir 310” which establishes fluid flow path), the lock configured to be transitioned from the first configuration to a second configuration (see para. [0109], lock is pressed inwards to a second configuration) to allow the distal coupler to be removed from the housing and with the distal coupler removed,
and wherein the first configuration to the second configuration to allow bodily fluid flow, via the fluid communicator 350, from the proximal end potion of the housing to a sample reservoir at least partially disposed in the distal end portion of the housing (see para. [0111], “With the desired amount of bodily-fluid disposed in the fluid reservoir 310, the fluid reservoir 310 can be moved in the proximal direction to, for example, remove the fluid reservoir 310 from the inner volume 336 of the transfer adapter 320. In some instances, a second fluid reservoir (not shown) can be inserted into the transfer adapter 320 and placed in fluid communication with the flow of bodily-fluid in the patient in substantially the same manner as described above. Thus, any suitable number of fluid reservoirs can be inserted into the transfer adapter 320 such that a piercable surface of each fluid reservoir is disinfected prior to receiving a flow of bodily-fluid”(emphasis added) indicating that after removal of the distal coupler, the lock can transition from the first to the second transition by coupling a sample reservoir).
Chetham fails to teach wherein, with the distal coupler removed, the lock is configured to be transitioned from the second configuration to the first configuration to maintain the stage in the first position to limit access to the fluid communicator via the distal end portion of the housing. It is noted that the limitation “to the first configuration to maintain the stage in the first position to limit access to the fluid communicator via the distal end portion of the housing,” is not positively recited and therefore does not hold patentable weight. The limitation merely recites how it is intended to be used.
Schmitt teaches a blood collection device comprising a housing (see figs. 1-4, housing 4) comprising a stage (34) that can be transitioned from a first configuration to a second configuration, and can be locked in either configuration to position a fluid communicator/needle in a retracted (encased within the device) or extended position after removing the distal coupler 68 (see column 4 [lines 25-63] and fig. 5). Furthermore, Schmitt acknowledges that the locking mechanism is for achieving a simple yet effective method for securing the needle in either position and the locking mechanism can take the form of other possible configurations.
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Schmitt, such that the stage is locked while in the second configuration, as taught by Schmitt, to aid in securing the needle in a simple yet effective method.
Regarding claims 2 and 22, Bullington teaches wherein the stage is allowed to be moved to a second position when the lock is in the second configuration (see fig. 4, upon removal of the coupler, the stage will return back to a substantially flat structure).
Regarding claims 3 and 23, Bullington fails to teach wherein the lock is configured to be transitioned from the second configuration to the first configuration after removing the distal coupler from the housing to prevent the stage from being moved from the first position toward the second position.
Schmitt teaches a blood collection device comprising a housing (see figs. 1-4, housing 4) comprising a stage (34) that can be transitioned from a first configuration to a second configuration, and can be locked in either configuration to position a fluid communicator/needle in a retracted (encased within the device) or extended position after removing the distal coupler 68 (see column 4 [lines 25-63] and fig. 5). Furthermore, Schmitt acknowledges that the locking mechanism is for achieving a simple yet effective method for securing the needle in either position and the locking mechanism can take the form of other possible configurations. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Bullington, such that the lock is configured to prevent the stage from moving, as taught by Schmitt, to aid in achieving a simple and effective way of securing the fluid communicator in a retracted or extended configuration.
Regarding claims 4 and 24, Bullington teaches wherein the fluid communicator is a needle (see para. [0082], needle) having a sharpened distal end portion, the stage (240) configured to limit access to the sharpened distal end portion of the needle when in the first position (the stage limits access to the needle until the distal coupler is inserted or removed in any of the configurations).
Regarding claim 5, Bullington teaches wherein the fluid collection device (300) is configured to receive a volume of bodily fluid via the fluid communicator when the lock is in the first configuration (see para. [0102, 0111], “port 324 that can be physically and fluidically coupled to any suitable lumen defining device such as a catheter, cannula, needle, trocar, or the like. For example, in some embodiments, the port 324 can be a Luer Lok.RTM. that can be physically and fluidically coupled to a peripheral intravenous (IV) needle and/or the like, as described with reference to the port 224 of the transfer adapter 220” and “the puncture member 350 can place the fluid reservoir 310 in fluid communication with the flow of bodily-fluid in the patient” and “In some instances, a second fluid reservoir (not shown) can be inserted into the transfer adapter 320 and placed in fluid communication with the flow of bodily-fluid in the patient in substantially the same manner as described above. Thus, any suitable number of fluid reservoirs can be inserted into the transfer adapter 320 such that a piercable surface of each fluid reservoir is disinfected prior to receiving a flow of bodily-fluid” (emphasis added)) .
Regarding claims 6 and 26, Bullington teaches wherein the fluid communicator configured to extend into the sample reservoir (see para. [0111], while the sample reservoir is not shown, sample reservoir 310 will be used as an example as it encompasses “ any suitable number of fluid reservoirs can be inserted into the transfer adapter 320 such that a piercable surface of each fluid reservoir is disinfected prior to receiving a flow of bodily-fluid”) when the sample reservoir 310 is disposed in the distal portion of the housing (fig. 12) to allow at least a portion of the volume of bodily fluid to be transferred from the fluid collection device 300 to the sample reservoir via the fluid communicator (see para. [0111], “the puncture member 350 is in fluid communication with the inner volume of the fluid reservoir 310” indicating that the fluid is transferred from the proximal end of the fluid collection device through the fluid communicator to the sample reservoir 310).
Regarding claim 27, Bullington-Schmitt teach wherein the lock is configured to be transitioned from the first configuration back to the second configuration to allow the sample reservoir to be disposed in the distal end of the housing and bodily fluid to flow (see fig. 12 of Bullington, the lock is transitioned to allow for coupling with reservoir), via the fluid communicator (Id. 350), from the proximal end portion of the housing to the sample reservoir (Id. Fluid communicator 350 is attached to the proximal end of the housing and ).
Response to Arguments
Applicant's arguments filed 07/26/2025 have been fully considered but they are not fully persuasive.
Applicant’s argues that Schmitt does not teach or reasonably suggest modifying Bullington in a manner that would render amended claim 1obvious to one of ordinary skill in the art, on page 7 of the Remarks. The examiner disagrees. Applicant fails to provide a reasoning as to why the combination would work. It appears the issue is whether one of ordinary skill in the art would incorporate a lock feature to the stage of Bullington. While the purpose of the stage in Bullington is to provide a disinfectant to the coupled reservoir surface, Schmitt teaches a moveable stage that is positioned within the housing similar to Bullington. Schmitt further teaches the additional feature of a locking mechanism while the needle is not being used, e.g., retracted. This arrives to Schmitt’s intended purpose, to provide a fluid collection device that is capable of keeping a retracted needle safely within the housing, thereby reducing accidents and providing a disinfected needle (see abstract of Schmitt). Both Bullington and Schmitt therefore teach the importance of maintaining a sterile environment for the needle, and provide mechanisms that one of ordinary skill in the art can incorporate to overcome situations that lead to contamination.
Therefore, Applicant’s arguments are found unpersuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN NATHAN ORTEGA whose telephone number is (571)270-7801. The examiner can normally be reached M-F 7:10 am - 5:00 pm.
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791