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 .
Claims Accounting
Applicant's arguments, filed 06/12/2026, have been fully considered.
The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 06/12/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 30, 32-35 and 37 have been amended.
Claim 36 has been cancelled.
Claims 51 and 52 are newly presented.
Claims 30, 32-35, 37 and 50-52 are the current claims hereby under examination.
Information Disclosure Statements
The information disclosure statement (IDS) submitted on 06/12/2026 has been considered by the examiner.
Non-patent literature citations 184-185 and 189-190 were not considered as these documents do not contain a date. Non-patent literature citations 211-212, 230, 232, 236, 239, 267, 275, 278, 312-314, 316-322, 328-334, 336-343, 345-347, 349, 351-354, 356-365, 367-368 and 380 were not considered as copies of these documents were not provided.
Foreign patent document citations 157 and 169 were not as copies of these documents were not provided.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 37 and 51-52 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.
Regarding claim 37, the claim recites the limitation "when the portion of the actuator mechanism receives the portion of the external fluid reservoir" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. There is no previous recitation of a portion of the actuator mechanism receiving a portion of the external fluid reservoir. Clarification is requested.
For the purposes of examination, the claim is interpreted as "when the outlet port is fluidically coupled to the portion of the external fluid reservoir" to be consistent with lines 15-16 of claim 30, from which claim 37 depends.
Regarding claim 51, the claim recites “when the actuator is in at least the second configuration or the third configuration” in lines 2-3. It is unclear what defined by “at least the second configuration or the third configuration”, as the phrase “at least” implies that the proceeding term refers a lower or minimum threshold. It is unclear how “the second configuration or the third configuration” can be interpreted as a lower or minimum threshold. In the progression of configurations, the second configuration comes before the third configuration, and would be considered the lower or minimum threshold between the two configurations. Clarification is requested.
For the purposes of examination, the claim is interpreted as “when the actuator is in at least the second configuration”. This interpretation encompasses when the actuator mechanism is in the second or third configuration.
All claims not explicitly addressed above are rejected under 35 U.S.C. 112(b) are rejected by virtue of their dependency on a rejected base claim.
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, 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 30, 32-37, and 50-52 are rejected under 35 U.S.C. 103 as being obvious over US Patent Publication 2014/0163419 by Bullington et al. – previously cited, hereinafter “‘419” in view of US Patent Publication 2013/0116599 by Bullington et al. – cited by Applicant, hereinafter “’599”.
Regarding claim 30, ‘419 teaches a bodily-fluid transfer device (Figs. 2-6, [0046]; syringe-based transfer device 200 is also considered a "bodily-fluid transfer device") the transfer device comprising:
a housing defining an inner volume ([0047]; housing 201 defines inner volume 211), a distal end portion of the housing forming an inlet port in fluid communication with the inner volume ([0047-0048]; Inlet port 205 is in the distal end portion of the housing 201 and in fluid communication with the inner volume as shown in Figs. 5 and 6);
and an actuator mechanism disposed in the inner volume of the housing (actuator 240) and configured to be transitioned from a first configuration to a second configuration to allow an initial volume of bodily-fluid to flow through the inlet port and into a first reservoir within a portion of the actuator mechanism (The change from the first to second configurations are shown in Figs. 4-5. This action allows fluid to flow through the inlet port via valve 270 as shown by arrow BB to first fluid reservoir 280. The first fluid reservoir is within the actuator mechanism),
after the initial volume is in the first reservoir, the actuator mechanism configured to be transitioned from the second configuration to a third configuration to allow a subsequent volume of bodily-fluid to flow into a second reservoir outside of the actuator mechanism (Figs. 5-6 show the transition from the second configuration to the third configuration. The movement of the actuator mechanism in the direction of arrow CC (Fig. 6) Allows the bodily fluid to flow into second reservoir 290 as shown by arrow DD).
‘419 does not teach an outlet port in fluid communication with the inner volume, the outlet port being separate from the inlet port, and after the subsequent volume of bodily-fluid is in the second reservoir, the outlet port configured to be fluidically coupled to an external fluid reservoir to allow at least a portion of the subsequent volume of bodily-fluid to flow from the second reservoir to the external fluid reservoir via the outlet port.
‘599 teaches a bodily-fluid transfer device configured to change from a first configuration to a second configuration to a third configuration. ‘599 teaches a first configuration where the inlet port does not permit the flow of fluid into any reservoir, and in the second configuration, a plunger moves to define the first reservoir 380. In the third configuration, the first reservoir is fluidically separate from the newly defined second volume (i.e., second reservoir, See annotated Fig 18 below), which is then in fluid communication with the inlet port (see Figs. 16-18). The outlet port is in fluid communication with the second reservoir when the second plunger 360 moves to define the second reservoir, as indicated by arrow II (Fig. 18). The outlet port is fluidically coupled to external fluid reservoir 390 and allows bodily fluid to flow through the second volume to the external reservoir. The inclusion an outlet port and an external fluid reservoir allows the external reservoir to be decoupled from the transfer device, such that the transfer device can be safely discarded separate from the desired sample ([0094]).
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Annotated Fig. 18 of ‘599
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the transfer device of ‘419 such to include an outlet port in fluid communication with the inner volume, the outlet port being separate from the inlet port, and after the subsequent volume of bodily-fluid is in the second reservoir, the outlet port configured to be fluidically coupled to an external fluid reservoir to allow at least a portion of the subsequent volume of bodily-fluid to flow from the second reservoir to the external fluid reservoir via the outlet port, in order to safely discard the transfer device separate from the desired sample, as taught by ‘599 ([0094]).
It is noted that the outlet port of ‘599 is blocked by the plungers in the first configuration while the plunger occupy the space that will turn into the second reservoir. When the plunger is moved out of the way, the second reservoir is defined and is in fluid communication with the outlet port. Therefore it would be obvious, in the combination of ‘419 and ‘599, to place the outlet port where the second reservoir is defined in the third configuration, and where it would be blocked by the plungers in the first configuration. The only place that corresponds to both conditions is identified in annotated Fig. 4 of ‘419 below.
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Annotated Fig. 4 of ‘419
Regarding claim 32, ‘419 in view of ‘599 teaches the transfer device of claim 30, wherein the actuator mechanism has a first member (‘419, [0049] first member 241) and a second member (‘419, second member 251), the first reservoir is positioned within the first member (‘419, Fig. 5, [0049]; the portion of inner volume 246 is defined by the first member and is defined as the first reservoir 280).
Regarding claim 33, ‘419 in view of ‘599 teaches the transfer device of claim 32, wherein teaches the first member forms a channel (‘491, [0051]; the distal end of first member 241 includes a plunger 247, which includes a channel 248), the inlet port and the channel collectively define a fluid flow path that allows the initial volume of bodily-fluid to flow from the inlet port to the first reservoir in response to the actuator mechanism transitioning from the first configuration to the second configuration (‘491, Fig. 5, [0058]; “As shown by the arrow BB in FIG. 5, the port 205, the valve 270, and the channel 248 define a fluid flow path that places the first reservoir 280 in fluid communication with the lumen-defining device”. It is noted that the transition from Fig. 4 to Fig. 5 establishes this fluid flow, and corresponds to the transition of the first configuration to the second configuration).
Regarding claim 34, ‘419 in view of ‘599 teaches the transfer device of claim 33, and further teaches the actuator mechanism includes a valve in the channel of the first member (‘491, [0051]; valve 270), the valve is in an open state to allow the initial volume of bodily-fluid to flow through the fluid flow path in response to a negative pressure differential in the first reservoir as a result of the actuator mechanism being moved from the first configuration to the second configuration (‘491, [0058]; “Expanding further, the negative pressure within the first reservoir 280 can be operative in moving the valve 270 from a closed configuration to an open configuration. In this manner, the negative pressure within the within the first reservoir 280 produced by the movement of the plunger 257 introduces a suction force within the portion of the patient. Thus, a bodily-fluid is drawn through the port 205 and the valve 270 and into the first reservoir 280.”), and the valve is in a closed state when the actuator mechanism is transitioned from the second configuration to the third configuration (‘491, [0060]; After the first reservoir is filled, the pressure normalizes and the valve 270 returns to a closed configuration. Therefore, in the transition from the second to third configuration, the valve must be in a closed state).
Regarding claim 35, ‘419 in view of ‘599 teaches the transfer device of claim 32, wherein the first member includes a plunger (‘491, [0051], the distal end of first member 241 includes a plunger 247), and a portion of the inner volume of the housing between the inlet port and the plunger of the first member forms the second reservoir (‘491, Fig. 6, [0062]; “The arrangement of the first member 241 within the inner volume 211 of the housing 201 is such that the proximal motion of the first member 241 increases the volume of the portion of the inner volume 211 that is distal of the plunger 247, thereby defining the second reservoir 290.”. As seen in Fig. 6, the end of second reservoir 290 opposite of plunger 247 is the inlet port 205).
Regarding claim 37, ‘419 in view of ‘599 teaches the transfer device of claim 30, wherein the outlet port is coupled to a puncture member configured to puncture a seal of the external fluid reservoir when the portion of the actuator mechanism receives the portion of the external fluid reservoir (‘599, [0083, 0085], the outlet port includes port 323, which can include a needle 326 to pierce a pierceable septum 393 of the external reservoir 390. The piercing occurs when the external reservoir is introduced to the outlet port, which defines a part of the transfer device).
Regarding claim 50, ‘419 in view of ‘599 teaches the transfer device of claim 32, and further teaches at least a portion of the second member is configured to move relative to each of the housing and the first member to transition the actuator mechanism from the first configuration to the second configuration (‘491, Fig. 5 [0056]; “More specifically, the user can engage the engagement portion 258 of the second member 251 included in the actuator mechanism 240 to move the actuator mechanism 240 from its first configuration to its second configuration, thereby placing the transfer device 200 in the second configuration, as indicated by the arrow AA in FIG. 5. In this manner, the second member 251 of the actuator mechanism 240 is moved in a proximal direction relative to the first member 241”), and the first member and the second member move together after the actuator mechanism is in the second configuration to transition the actuator mechanism from the second configuration to the third configuration. (‘491, Fig. 6, [0061]; “With the first amount fluidically isolated, the actuator mechanism 240 can be moved from the second configuration to a third configuration by further moving the actuator mechanism 240 in the proximal direction… the further application of force on the engagement portion 258 is such that the first member 241 and the second member 251 collectively move in the proximal direction relative to the housing 201.”)
Regarding claim 51, ‘419 in view of ‘599 teaches the transfer device of claim 30, wherein the first member includes a plunger configured to define at least a portion of the second reservoir when the actuator is in at least the second configuration and the third configuration (See the rejection of claim 35. ‘491, Fig. 6, [0062]; “The arrangement of the first member 241 within the inner volume 211 of the housing 201 is such that the proximal motion of the first member 241 increases the volume of the portion of the inner volume 211 that is distal of the plunger 247, thereby defining the second reservoir 290.” This occurs in the third configuration (Fig. 6)).
Regarding claim 52, ‘419 in view of ‘599 teaches the transfer device of claim 51, wherein the actuator mechanism is configured such that the plunger fluidically isolates the outlet port from the inlet port prior to the actuator mechanism being transitioned from the second configuration to the third configuration (In the combination of ‘419 and ‘599, the plunger blocks the outlet port in the first configuration, fluidically isolating it from the inlet port. See the rejection of claim 30).
Response to Arguments
Applicant’s arguments, filed 06/12/2026 have been fully considered.
The amendments to claims 32 and 35 overcome the objections of record.
The amendments to the claims overcome the rejections under 35 U.S.C. 112(b) of claims 30 and 35. The amendments to the claims necessitate new rejections of claims 37 and 51 under 35 U.S.C. 112(b).
Applicant’s assertion regarding the rejection of claim 30 under 35 U.S.C. 102(a)(1) is acknowledged. This assertion is moot as it is based on amendments to the claims not entered at the time of the previous Office action. The newly presented limitations are rejected on new grounds 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 NELSON A GLOVER whose telephone number is (571)270-0971. The examiner can normally be reached Mon-Fri 8:00-5:00 EST.
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/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
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