A Combined Sample Collection And Filtration Device
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
Receipt is acknowledged of Applicant’s reply filed 04/24/2026 which has amendments to the claims and Applicant's arguments related to the previous rejection. The above have been entered and considered.
Response to Arguments
Applicant argues the amendment to claim 7 obviates the rejection under 112(b). The examiner is persuaded and withdraws the rejection.
Applicant argues Fruchter’s plunger, with regard to the examiner’s previous assertion concerning a distinction between the terms “sealing” and “sealing off”, seals with the wall of the housing but does not seal off the space occupied by the piston.
The examiner is not persuaded. The distinction between “sealing” and “sealing off” was made in response to applicant’s argument that the term closure refers to a physical element which seals off an opening and Webster merely uses a capillary pressure barrier to halt or temporarily prevent the flow of liquid. At that point in the prosecution, the BRI of applicant’s claim did not distinguish between Webster’s pressure barrier and a physical element that blocks an opening. The examiner maintains that Webster’s capillary stops create closures that are designed to seal by preventing material from passing through without a predetermined pressure being applied. The examiner asserts Fruchter’s plunger head shaped to form a seal with the wall is for completely blocking the upstream opening of the liquid container, thus sealing off the opening.
Further, applicant argues Fruchter’s plunger head only forms a liquid-tight or liquid-impermeable seal and therefore does not completely block or seal off the environment.
The examiner is not persuaded. Applicant’s examples from Fruchter’s disclosure citing a liquid-tight or liquid-impermeable seal are referring to Fruchter’s coupling of the upstream component and downstream component, not Fruchter’s plunger head. Fruchter’s plunger assemble is similar to a conventional syringe. A PHOSITA would recognize Fruchter’s plunger seals off the liquid container inlet and allows pressurization of the container. The rejection is therefore maintained.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 is incorrect, any correction of the statutory basis 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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 5-6, 12 and 17-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Fruchter (US 20210215585, “Fruchter”).
Regarding claim 1, Fruchter discloses, in figures 1-4, a combined sample collection and filtration device (20) for collecting and filtering a fluid sample (22), the device comprising: a sample collection location (36); a filter module (32) configured to remove particulate matter from the fluid sample (22), the filter module (32) having a bubble point and a burst pressure (the examiner asserts a wetted filter has an inherent bubble point and filters have an inherent burst pressure); a closure for sealing off and pressurizing (¶ 0139, examiner notes the plunger head is shaped for form a seal with the wall of the housing to pressurize the liquid container and force liquid through the filter) the device (20); and one or more voids (30, 46) in communication with the sample collection location (30), the one or more voids (30, 46) each comprising a compressible gas (see fig. 1, examiner notes Fruchter depicts the liquid receptacle and filter chamber to be initially filled with a gas), wherein the one or more voids (30, 46) are configured to accommodate a fluid sample during pressurization (see fig. 1B, examiner notes Fruchter’ s liquid receptacle and filter chamber receives liquid pushed by the plunger through the filter), and wherein the device (20) is configured to compress or expel the compressible gas from the one or more voids during pressurization, such that the pressure within the device remains below the bubble point and the burst pressure of the filter module (examiner notes that the limitation, “configured to compress or expel… from the one or more voids during pressurization, such that the pressure… remains below the bubble point and the burst pressure of the filter module” is a functional language type limitation. Applicant is reminded that functionality must be distinguished from the prior art structure's inherent functionality. In the instant case, Fruchter’s device is capable of compressing gas in the liquid receptacle and filter chamber so that the pressure remains below the bubble point and the burst pressure of the filter, See MPEP 2114.).
Regarding claim 3, Fruchter discloses, in figures 1-4, there is a plurality of voids (30, 46, 36, 344) separated by a plurality of partitions (see fig. 4, Fruchter depicts a cross-section of the filter chamber partition separating the filter chamber from the liquid receptacle, further Fruchter depicts the vials separated by the plunger shaft).
Regarding claim 5, Fruchter discloses, in figures 1-4, a compressible absorptive pad (58).
Regarding claim 6, Fruchter discloses, in figures 1-4, the compressible absorptive pad (58) is removable (¶ 0354, examiner notes the swab can be inserted into and removed from the liquid).
Regarding claim 12, Fruchter discloses, in figures 1-4, a check-valve (51, 60) in fluid communication with the filter module (32).
Regarding claim 17, Fruchter discloses, in figures 1-4, the one or more voids (30, 46, 344) further comprises a plunger element (40) for separating fluid sample (22) from gas in the one or more voids (30, 46, 344) and for preventing the fluid (22) sample from flowing off the filter module (32).
Regarding claim 18, Fruchter discloses, in figures 1-4, the one or more voids (30, 46, 344) comprise an air vent (361) configured to allow air (¶ 0306, Fruchter’s second pressure relief valve is capable of relieving air pressure to the environment) to escape the device (90).
Regarding claim 19, Fruchter discloses, in figures 1-4, a deformable (¶ 0306, Fruchter’s second pressure relief valve open when exposed to a pressure gradient greater than a threshold) barrier (361) to the one or more voids (30, 344) for separating fluid sample (22) from gas (¶ 0306, Fruchter’s second pressure relief valve is capable of relieving air pressure to the environment) in the one or more voids (30) and for preventing the fluid sample(22) from flowing off the filter module (32).
Regarding claim 20, Fruchter discloses, in figures 1-4, the one of the voids (344) comprises an air vent configured to allow air to escape (see fig. 4B) the device (20).
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 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Fruchter (US 20210215585, “Fruchter”) as applied to claim 1 above, and further in view of Andeshmand (US 20210047678; “Andeshmand”).
Regarding claim 8, Fruchter fails to disclose porosity details of the filter.
Andeshmand teaches the filter module (¶ 0338, “size-exclusion filter”) comprises a plurality of filter- membranes and wherein porosity is graded to prevent membrane clogging (¶ 0338, Andeshmand’s filter retains particles larger than its pore size on the upstream surface of the filter and captures particles with a diameter below the rated pore size by mechanisms within the membrane structure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Andeshmand’s size-exclusion filter design with internal mechanisms for retaining smaller size particles to define Fruchter’s filter. Doing so reduces the rate of filter fouling.
Regarding claim 9, Fruchter and Andeshmand disclose, in Fruchter’s figures 1-4, a support structure (Fruchter, ¶ 0055, “filter-support surface”) residing between the filter membrane (¶ 0228, Fruchter’s filter comprises membranes) and a compression compartment (Fruchter (36)).
Regarding claim 10, Fruchter and Andeshmand disclose, in Fruchter’s figures 1-4, a guard (not enumerated, see fig. 1, examiner notes the sides of the liquid container at the filter level act to center and guard the filter against movement).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Fruchter (US 20210215585, “Fruchter”) and Andeshmand (US 20210047678; “Andeshmand”), as applied to claim 8 above, in view of Webster (US 20200009554; “Webster”).
Regarding claim 11, Fruchter and Andeshmand fail to disclose the wetting coefficient of the filter.
Webster teaches, in figure 2, the filter membrane (140) of the filter module (112, 140) has a positive wetting coefficient (¶ 0059, Webster’s wetted filter prevents pressurized gas from passing through therefore liquid spreads over the entire surface and is construed to have a positive wetting coefficient) and is configured to wick (Webster, ¶ 0059, “excess sample material 102 in the sample well port 112 may be allowed to wick into the fluidic channel 120”) in the fluid sample (102) and to thereby form a seal (Webster, ¶ 0059, “the filter 140 may effectively act as a seal for gas”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Webster’s positive wetting coefficient filter as Fruchter and Andeshmand’s filter since it is well known to combine prior art elements according to known methods to yield predictable results. Doing so provides a reliable way of preventing additional gas from moving into the filter chamber.
Allowable Subject Matter
Claims 4, 7, 13-16 and 21 are 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.
Regarding claim 4, examiner notes a search has not revealed art teaching or suggesting the device of Fruchter wherein each void comprises a sealed volume that is compressed upon closure of the device. The examiner concludes prior existence of the combination is improbable.
Regarding claim 7, examiner notes a search has not revealed art teaching or suggesting the device of Fruchter wherein the closure comprises a one-way latch. The examiner concludes prior existence of the combination is improbable. The dependent claims would be allowable for at least the same reason as above.
Regarding claim 21, examiner notes a search has not revealed art teaching or suggesting the device of Fruchter wherein one of the voids comprises a bladder of compressible gas for separating fluid sample from gas in the one or more voids and for preventing the fluid sample from flowing off the filter module. The examiner concludes prior existence of the combination is improbable.
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 TIMOTHY P GRAVES whose telephone number is (469)295-9072. The examiner can normally be reached M-F 8 a.m. - 5 p.m..
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, Peter Macchiarolo can be reached at 571-272-2375. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY P GRAVES/ Primary Examiner, Art Unit 2855
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