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 .
This Office Action is responsive to the Reply to Office Action filed March 25, 2025. The Examiner acknowledges the amendments to claims 34, 35, 37, 42, 44, 45, 47 and 49, the cancellation of claims 1-29 and 31, and new claim 50. Claims 30 and 32-50 are currently pending, with claims 38-49 being withdrawn from consideration.
Election/Restrictions
Applicant's election with traverse of Group I, Species 2, in the reply filed on March 25, 2025 is acknowledged. The traversal is on the ground(s) that there is no serious burden on the examiner to search and examine all of the claims in the application. This is not found persuasive because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement to effectively demonstrate the lack of burden on the examiner.
The requirement is still deemed proper and is therefore made FINAL.
Claims 38-49 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions and species, there being no allowable generic or linking claim.
Claim Objections
Claim 32 is objected to because of the following informalities: "The transfer device of claims 30" should read as --The transfer device of claim 30--.
Claim 35 is objected to because of the following informalities: "the first member including a plunger, a portion of the inner volume of the housing between the inlet port and the plunger of the first member forming the sample reservoir" should read as --the first member includes a plunger, and a portion of the inner volume of the housing between the inlet port and the plunger of the first member forms the sample reservoir--.
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 30, 32-37 & 50 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 30 recites “a pre-sample reservoir.” It is unclear what a pre-sample reservoir is, as the pre-sample reservoir is configured to receive an initial volume of bodily-fluid (i.e., how is the pre-sample reservoir “pre-sample” if it receives a volume of bodily fluid?). For examination purposes, the pre-sample reservoir will be interpreted as a first reservoir of the bodily-fluid transfer device.
Claim 35 recites “a sample reservoir.” It is unclear how the sample reservoir is different than the pre-sample reservoir as the sample reservoir is formed between the inlet and the plunger within the first member, as recited in claim 35, while the pre-sample reservoir is positioned in the first member as recited in claim 32 (i.e., as recited, it appears that the pre-sample reservoir and sample reservoir overlap in space). The examiner respectfully requests clarification of this claim limitation. For examination purposes, it will be interpreted that the sample reservoir fits into the pre-sample reservoir.
Dependent claims are similarly rejected as their base claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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.
Claim(s) 30, 32-37 & 50 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication 20140163419 --as cited by applicant--, hereinafter referenced as "Bullington".
With respect to claim 30, Bullington teaches a bodily-fluid transfer device 200 (i.e., a syringe-based fluid diversion mechanism for bodily fluid sampling) (see Bullington, abstract, par 0046, fig. 2), the transfer device comprising:
a housing 201 defining an inner volume 211 in fluid communication with an inlet port 205 configured to receive bodily-fluid from a patient (see Bullington, par 0046-0048, figs. 2 & 3);
and an actuator mechanism 240 disposed in the inner volume 211 of the housing 201 (see Bullington, fig. 2, par 0046-0049) and configured to be transitioned from a first configuration to a second configuration to allow an initial volume of bodily-fluid to flow into a pre-sample reservoir 280 (i.e., a first reservoir) in a portion of the actuator mechanism 240 (see Bullington, fig. 2, par 0046-0049),
after the initial volume is in the pre-sample reservoir 280 (i.e., the first reservoir), the actuator mechanism 240 configured to be transitioned from the second configuration to a third configuration to allow a subsequent volume of bodily-fluid to flow into a sample reservoir 290 (i.e., a second reservoir) outside of the actuator mechanism 240 (see Bullington, fig. 2, 5 & 6, par 0046-0049, 0059-0063),
and after the subsequent volume of bodily-fluid is in the sample reservoir, the transfer device configured to receive a portion of an external fluid reservoir 380 to allow at least a portion of the subsequent volume of bodily-fluid to flow from the sample reservoir to the external fluid reservoir via an outlet port 376 separate from the inlet port 205 (i.e., the transfer device can receive external reservoirs such as a vacutainer reservoir for transferring the fluid into the external reservoir for retaining the sample) (see Bullington, par 0069-0072, 0107, figs. 6 & 8).
With respect to claim 32, Bullington teaches the transfer device of claim 30, and further teaches the actuator mechanism 240 has a first member 241 and a second member 251, the pre-sample reservoir (i.e., the first reservoir) is positioned in the first member (i.e., the first member 241 defined an inner volume 246 wherein the inner volume 246 defines the first reservoir 280) (see Bullington, par 0049-0057, fig. 3).
With respect to claim 33, Bullington teaches the transfer device of claim 32, and further teaches the first member 241 forms a channel 248, the inlet port 205 and the channel 248 collectively define a fluid flow path that allows the initial volume of bodily-fluid to flow from the inlet port 205 to the pre-sample reservoir 280 in response to the actuator mechanism transitioning from the first configuration to the second configuration (i.e., the distal end portion of the first member 241 includes a plunger 247 that is configured to define a channel 248 that receives a valve 270, wherein the port 205, the valve 270 and the channel 248 define a fluid flow path with the first reservoir 280) (see Bullington, par 0051-0058, fig. 5).
With respect to claim 34, Bullington teaches the transfer device of claim 33, and further teaches the actuator mechanism 240 includes a valve 270 in the channel 248 of the first member 241, the valve 270 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 pre-sample reservoir 280 as a result of the actuator mechanism 240 being moved from the first configuration to the second configuration, and the valve is in a closed state when the actuator mechanism is transitioned from the second configuration to the third configuration (see Bullington, par 0051-0058, figs. 3-5).
With respect to claim 35, Bullington teaches the transfer device of claim 32, and further teaches the first member 241 includes a plunger 247, and a portion of the inner volume 211 of the housing 201 between the inlet port 205 and the plunger 247 of the first member forms the sample reservoir 290 (i.e., the second reservoir) (see Bullington, par 0051-0052, 0062-0063, figs. 3 & 6).
With respect to claim 36, Bullington teaches the transfer device of claim 35, and further teaches the outlet port 376 is disposed in a portion of the actuator mechanism proximal to the plunger, the portion of the actuator mechanism proximal to the plunger is configured to receive a portion of the external fluid reservoir when the actuator mechanism is in the third configuration (i.e., a channel of the plunger is configured to receive a port of an external fluid reservoir) (see Bullington, figs. 8-10, par 0069-0072, 0107).
With respect to claim 37, Bullington teaches the transfer device of claim 36, and further teaches the outlet port 376 is coupled to a puncture member 377 configured to puncture a seal of the external fluid reservoir 380 when the portion of the actuator mechanism receives the portion of the external fluid reservoir 380 (see Bullington, par 0069-0072, 0107, figs. 8-10).
With respect to claim 50, Bullington teaches the transfer device of claim 32, and further teaches at least a portion of the second member 251 is configured to move relative to each of the housing 201 and the first member 241 to transition the actuator mechanism 240 from the first configuration to the second configuration, and the first member 241 and the second member 251 move together after the actuator mechanism 240 is in the second configuration to transition the actuator mechanism 240 from the second configuration to the third configuration (see Bullington, par 0050, 0053-0054, 0060-0061, figs. 4-6).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Destiny J Cruickshank whose telephone number is (571)270-0187. The examiner can normally be reached M-F, 9am-6pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.J.C./Examiner, Art Unit 3791
/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791