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 .
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.
It is noted by the examiner that Claims 1-11 of the instant application depend on structure of the device. Therefore, evidence provided below for the given references will disclose and teach structural abilities and consistencies that line up with the instant application.
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.
Claims 1-3 and 8-11 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lintula’185 (U.S. Publication Number 20200108185 – previously cited).
Regarding Claim 1, and those that depend on it, it is noted by the examiner that while Lintula’185 teaches element 22 as the inlet port and element 24 as the outlet port, the referenced device is capable of using 22 as the outlet port and 24 as the inlet port. Evidence of this is further provided by the reference Lintula’185 as both the inlet and the outlet are configured to be connected to a tube as well as a suction device (Paragraph [0035] - inlet fitting 22 may be coupled to a tube engaged to a suction tool… outlet fitting 24 may be coupled to a tube that is connected to a suction source). Therefore, the examiner will further refer to the inlet as element 24 and the outlet as element 22 throughout the duration of the detailed action.
Regarding Claim 1, Lintula’185 discloses a filtration system (10) that filters medical aspirant obtained from a body of a subject (Paragraph [0005] - a filter assembly is provided for use with a surgical suction tool for removing fluid and debris from a surgical site), comprising:
a chamber (combination of 14,16, and 50) with a distal side including an inlet port (24) capable of receiving a sample from the body of the subject, a chamber interior (50) in communication with the inlet port (24), and a proximal side including an outlet port (22) in communication with the chamber interior (50) (Paragraph [0035] - the filter assembly includes an inlet tube fitting 22, incorporated into the cap 16, and an outlet tube fitting 24, incorporated into the container 14, with each fitting configured to engage standard medical tubing used in a surgical suction system; Figures 1-2 and 11); and
a filter (12) within the chamber interior (50), the filter (12) being elongated and including an open end (31), a closed end (40) (Paragraph [0035] - a filter assembly 10 includes a filter element 12, disposed within container 14; Paragraph [0028] - the filter body includes a mouth 31 open to an interior chamber 32 defined by a tapered or conical cylindrical wall 35; Paragraph [0036] - a bottom wall 40 closes the bottom of the interior chamber 32 so that the filter body is a truncated conical body), and
a filter interior (32) between the open end (31) and the closed end (40), the closed end (40) having a smaller dimension than the open end (31), the closed end (40) being oriented toward the inlet port (24) of the distal side of the chamber (45) such that the sample is capable of passing through the filter from an outer surface of the filter to an inner surface of the filter, the open end (31) being oriented toward the outlet port (22) of the proximal side of the chamber (combination of 14 and 16) such that a filtrate of the sample is capable of passing through the open end to the outlet port (22) (Paragraph [0005] - a filter element having an elongated truncated conical body including a mouth at one end, a closed bottom at an opposite end and a conically tapered wall between the mouth and bottom);
a catheter couplable to the inlet port of the chamber (Paragraph [0035] - fitting 24 may be coupled to a tube - catheter); and
an aspirator couplable to the outlet port of the chamber (Paragraph [0035] - fitting 22 may be coupled to a tube engaged to a suction tool - aspirator).
It is noted by the examiner that Lintula’185 discloses a chamber (combination of 14 and 16) with a cylindrical chamber interior (50) that is in communication with the inlet and outlet port via walls of the body (45) (as seen in Annotated Figure 1 below).
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Annotated Figure 1
Regarding Claim 2, Lintula’185 discloses the device outlined in Claim 1 above. Lintula’185 further discloses wherein the chamber interior (50) is cylindrical in shape and the filter (12) is conical or frustoconical in shape (Paragraph [0040] - the body 45 includes an upper cylindrical wall 50 that extends to a conical cylindrical wall 51 that corresponds to the conical wall of the filter element).
Regarding Claim 3, Lintula’185 discloses the device outlined in Claim 1 above. Lintula’185 further discloses wherein a wall of the chamber (combination of 14 and 16) is transparent (Paragraph [0036] - in one specific embodiment the body 30 is formed of a clear or substantially transparent medical grade polycarbonate).
Regarding Claim 8, Lintula’185 discloses the device outlined in Claim 1 above. Lintula’185 further discloses a tube that establishes communication between the aspirator and the outlet (22) of the chamber (combination of 14 and 16) (Paragraph [0006] - an outlet tube fitting adapted to engage a surgical tube connected to a suction source and/or a fluid container).
Regarding Claim 9, Lintula’185 discloses the device outlined in Claim 8 above. Lintula’185 further discloses wherein apertures of the filter (12) minimize interruption to flow of fluid through the filtration system (10) (Paragraph [0037] - the larger orifices in the uppermost portion of the filter element ensures sufficient suction and fluid flow even as debris is collected in the bottom of the filter element).
Regarding Claim 10, Lintula’185 discloses the device outlined in Claim 8 above. Lintula’185 further discloses wherein apertures of the filter (12) enable fluid to flow through the filter (12) at a same rate as the fluid can flow through the tube (Paragraph [0037] - the larger orifices in the uppermost portion of the filter element ensures sufficient suction and fluid flow even as debris is collected in the bottom of the filter element).
Regarding Claim 11, Lintula’185 discloses the device outlined in Claim 8 above. Lintula’185 further discloses a catheter that establishes communication between the body of the subject and the inlet (24) of the chamber (combination of 14 and 16) (Paragraph [0007] - an inlet tube fitting adapted to engage a surgical tube).
It is noted by the examiner that Claims 1-11 are presented as a system, and therefore can be anticipated by the above references due to the references showing a similar structure as the instant application’s system.
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Lintula’185 (U.S. Publication Number 20200108185 – previously cited) as applied to Claim 1 above, in view of Tan et. al.’361 (U.S. Publication Number 20170354361 – previously cited).
Regarding Claim 4, Lintula’185 discloses the device outlined in Claim 1 above. Lintula’185 further discloses a wall (50) of the chamber (combination of 14 and 16) (Paragraph [0040] - the body 45 includes an upper cylindrical wall 50), but does not disclose a wall of the chamber is flexible. However, Tan et. al.’361 teaches a wall of the chamber (561) is flexible (Paragraph [0023] - a flexible elastic bladder as a sample collection receptacle that may be squeezed to zero, or close-to-zero, volume with a key or screw drive to deliver a constant low pressure on the sample). It would be prima facie obvious to one of ordinary skill in the art to combine the walls (50) of the chamber (combination of 14 and 16) as disclosed in Lintula’185 with materials that are flexible as taught in Tan et. al.’361 so that the user may assist the process of moving a sample through the device without causing too much force or pressure on the sample. Movement of the sample, gently, helps keep the integrity of the sample as taught by Tan et. al.’361 (Paragraph [0022] - moving sample and separating sample components by substantially constant low pressures to avoid cell lysing). Furthermore, a skilled artisan at the time of the invention was filed would have recognized that the addition of the flexible walls seen in the bladder (561) in comparison to rigid walls would give the user a better idea of how much sample is collected and more control of the sample’s movement along the device without having to disrupt the process.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Lintula’185 (U.S. Publication Number 20200108185 – previously cited) as applied to Claim 1 above, in view of Idelevich et. al.’848 (ES Publication Number 2787848 – previously cited).
Regarding Claim 5, Lintula’185 discloses the device outlined in Claim 1 above. Lintula’185 further discloses wherein the filter (12) can slide within the chamber interior (50), along a length of the chamber interior (50) (Paragraph [0040] - the interior 47 – includes chamber wall 50 - of the container is sized and configured to receive the filter element 12 therein; Figure 1), but fails to disclose wherein the filter can slide within the chamber interior, along a length of the chamber interior, while enclosed within the chamber (emphasis added). Idelevich et. al.’848 discloses a filter can slide within a chamber interior, along a length of the chamber interior, while enclosed within the chamber (Page 12 Paragraph 2 - …the plunger moves up and down through this by pressure on the piston rod 116 (configuration as in Figure 2); Page 18 Paragraph 2 - …the filter element 136 must not be located in a separate filter chamber 134, but can be attached to the end of the plunger, which is present in the filter container. housing 110, 202. After taking a blood sample in housing container 202, the liquid proportion of the blood reaches, by pressure on the plunger and through the filter element 212 attached to the end of the plunger to a part of the housing container 202, for example to the part located behind the plunger cap, while pathogenic particles and cell debris possibly present after lysis of blood cells, remain in the other corresponding part). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have modified the apparatus of Lintula’185 wherein the filter (12) of Lintula’185 would include a movable filter that is able to slide along the length of the chamber interior while enclosed in order to push fluid through the filter while keeping debris separate as seen in Idelevich et. al.’848 (see above Page and Paragraph; Page 6 last Paragraph - the plunger can be used to drive the liquid from one compartment of the receiving container to another compartment of the receiving container, the plunger cap then being permeable for the liquid only in one direction and can be considered as a wall separation between compartments).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Lintula’185 (U.S. Publication Number 20200108185 – previously cited) in view of Idelevich et. al.’848 (ES Publication Number 2787848 – previously cited) as applied to Claim 5 above, and further in view of Tan et. al.’361 (U.S. Publication Number 20170354361 – previously cited).
Regarding Claim 6, Lintula’185 in view of Idelevich et. al.’848 discloses the device outlined in Claim 5 above. Lintula’185 further discloses a chamber (combination of 14 and 16) (Paragraph [0040] - the body 45), but does not disclose a spring within the chamber interior. Tan et. al.’361 teaches a spring (302) within the chamber interior (Paragraph [0023] - manually compressed or elongated springs that are released to deliver a substantially constant force). 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 system of Lintula’185 in view of Idelevich et. al.’848 to include a spring (302) as taught by Tan et. al.’361 within the interior (47) of a chamber (combination of 14 and 16) as disclosed by Lintula’185 in order to provide an additional mechanism to help control and assist pressure flow throughout the device between the filter (12) and the aspirator. Tan et. al.’361 teaches the spring’s (302) enablement for controlled force in a device (Paragraph [0023] - manually compressed or elongated springs that are released to deliver a substantially constant force on a sample collection receptacle). Furthermore, a skilled artisan at the time of the invention was filed would have recognized that the addition of the spring mechanism (302) assisting the device with constant pressure would be beneficial for the sample in order to avoid possible destruction of the sample such as those taught by Tan et. al.’361 above (Paragraph [0022] - moving sample and separating sample components by substantially constant low pressures to avoid cell lysing).
Regarding Claim 7, Lintula’185 in view of Idelevich et. al.’848 discloses the device outlined in Claim 6 above. Lintula’185 further discloses a filter (12) and chamber (combination of 14 and 16) (Paragraph [0035] - a filter element 12, disposed within container 14; Paragraph [0036] - the filter body includes a mouth 31 open to an interior chamber 32), but does not disclose the spring comprises a compression spring within the chamber interior, between the filter and the proximal side of the chamber. Tan et. al.’361 teaches wherein the spring (302) comprises a compression spring (302) within the chamber interior, between the filter (202) and the proximal side of the chamber (300) (Paragraph [0049] - spring-loaded plunger draws blood through a filter stack that is integrated inside the tip; Figure 3; Paragraph [0070] - contains compression spring (302)). 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 system of Lintula’185 in view of Idelevich et. al.’848 to add compression springs (302) as taught in Tan et. al.’361 to be placed between the filter (12) and chamber (combination of 14 and 16) disclosed in Lintula’185 rather than other spring types because the compression springs (302) allows for better control of fluid through a device while the compression spring (302) goes through different positioning states. Tan et. al.’361 taught how different spring types depend on the desired function/role of the springs (Paragraph [0070] - it would be understood by one of ordinary skill that embodiments with different spring types may be used, including but not limited to, a compression spring that is place in an over stretched state, then released to drive fluid through filters as it moves to a relaxed state). Furthermore, a skilled artisan at the time of the invention was filed would have recognized that the addition of the compression springs (302) between the filter (12) and chamber (combination of 14 and 16) would allow the user to control movement of the sample through the filter (12) to enable sufficient flow during different periods of the extraction process which would aid in the orifices of the filter (12) disclosed in Lintula’185 (Paragraph [0037] - the larger orifices…of the filter element ensures sufficient suction and fluid flow).
Response to Arguments
Applicant's arguments filed 04 March 2026 have been fully considered and they are not entirely persuasive.
Applicant’s amendments have not overcome the prior rejections under 35 U.S.C. 102 regarding Claims 1-3 and 8-11 for the reasons addressed in Paragraph 4 above. However, the examiner notes that additional art has been cited in the pertinent art section in Paragraph 9 below that teaches on a medical filtration device containing a catheter and aspirator. Claims 4-7 are all rejected under 35 U.S.C. 103 as addressed in Paragraphs 5-7 above.
Additionally, the examiner’s rationale for an “inlet” and “outlet” port being interchangeable stand given that Lintula’185 recites both ports being connected to tubing capable of being connected to a suctioning tool as addressed in Paragraph 4 above.
Regarding Claim 2, the examiner’s prior reasons for rejection stand given the recitation of the claim language not reciting that the entirety of the inside of the container must is cylindrical in shape. Additionally, the examiner notes that the applicant has failed to provide details of criticality or unexpected results in the specification with regard to the entirety of the chamber interior be cylindrical. The examiner draws attention to Section 2144.04 of the MPEP Subsection IV.A. that recites “the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984).
As Claims 1-11 are not allowable for the reasons discussed above, rejoinder of Claims 12-20 was not considered.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gilbert et. al.’244 (U.S. Publication Number 20150168244) discloses a device wherein a catheter coupled to one port of a chamber and an aspirator coupled to another port of a chamber (Paragraph [0088] - distal end 112 may have a diameter and be formed with a "catheter tip" shape suitable for mating; Paragraph [0085] – proximal end port 104 is coupled to a source vacuum or suction as to draw or aspirate fluid).
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 SARAH ANN WESTFALL whose telephone number is (571) 272-3845. The examiner can normally be reached Monday-Friday 7:30am-4:30pm EST.
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, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH ANN WESTFALL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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