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 .
Remarks
This office action fully acknowledges Applicant’s remarks and amendments filed on 13 May 2026.
Claims 1-7, 9-11, 13-18, and 26-27 are pending.
Claim 1 is amended.
Claims 8, 12, and 19-25 are canceled.
No claims are withdrawn.
Claims 26 and 27 are newly added.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-7, 9, 11, and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over McIntyre et al. (US 2019/0201888 A1), referred to hereinafter as “McIntyre”, in view of Smith (US PAT 6,622,882 B2), referred to hereinafter as “Smith”, Ciliberto et al. (US PAT 6,929,782 B1), referred to hereinafter as “Ciliberto”, and Maxim et al. (US 2017/0097344 A1), hereinafter “Maxim”.
Regarding Claim 1, McIntyre teaches a cover for a fluid container comprising:
an essentially plane cover plate 116 (“base 116”) for closing at least one opening of at least one fluid container 102 (Fig. 1A, see also Claim 16: “the cap hermetically seals the biological-fluid container”),
a first port 106 and a second port 108 (Fig. 1A and [0020]: “The cap 104 also includes an injection-port cap configured to attach to the injection port 106 and an extraction-port cap configured to attach to the extraction port 108…”),
wherein each of the first port 106 and the second port 108 comprises a separate through channel extending through an entire thickness of the cover plate 116 (Fig. 1B and [0034]: “…the injection port 106 and extraction port 108 include cannulas or conduits configured to extend into the biological-fluid container 102.”),
a fluid impermeable first membrane 110 (“cap 110”) arranged over an entire cross section of the through channel of the first port 106 (Fig. 1C and [0004]: “…a cap can include a penetrable flexible seal configured for insertion and extraction of biological fluid through the flexible seal.” – The penetrable flexible seal is interpreted as a membrane given that a membrane is defined as “a thin soft pliable sheet or layer” (Merriam-Webster Dictionary).),
an at least gas permeable second membrane 112 (“cap 112”) is arranged over an entire cross section of the through channel of the second port 108 ([0004]: “…at least one of the injection-port cap or the extraction-port cap is a vented cap.”),
as in Claim 1.
Further regarding Claim 1, McIntyre does not specifically teach the cover for a fluid container discussed above wherein the first membrane is arranged on a shoulder formed within the through channel of the first port, as in Claim 1.
However, Smith teaches a respective container cover wherein a membrane 73A is arranged on a shoulder formed within the through channel 55 of a port covered by the cap 44 (Fig. 6B and [col. 13, line 12]: “…an insert molded self-sealing thermoplastic elastomer septum, Item 73A. This configuration allows for aseptic injection of reagents or withdrawal of sample without compromising the sterility or integrity of the contents by venting the sealed closure 40 through vent channel 55.”).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the container cover of McIntyre with a membrane arranged on a shoulder formed within the through channel of the port, such as suggested by Smith, so as to provide a sufficient structure to secure the membrane in place and prevent leaks that could compromise the sterility and integrity of contents secured therewithin; and would have a reasonable expectation of success therein.
Further regarding Claim 1, McIntyre does not specifically teach the cover for a fluid container discussed above wherein a holding plate arranged on an inner side of the cover plate, wherein the membranes are clamped between the cover plate and the holding plate, and wherein the holding plate comprises through channels that are aligned with corresponding through channels of the cover plate, as in Claim 1.
However, Ciliberto teaches a respective sample container cover comprising a cover plate 18, a holding plate 20, and a membrane 30 clamped therebetween, wherein an aperture 38 of the cover plate 18 and an aperture 26 of the holding plate 20 are aligned to allow fluid to pass through the membrane 30 (Fig. 1 and [col. 5, line 13]: “Ring 18 interfits coaxially within end cap 20 on top of membrane 30, the membrane being sandwiched between ring 18 and support surface 28…”), thereby sealing the structure so fluid only passes through the membrane ([col. 6, line 5]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the container cover of McIntyre to include a holding plate for securing the membrane to the cover plate, such as suggested by Ciliberto, so as to provide a sufficient structure for mounting the membrane and sealing it so liquid only passes through the membrane; and would have a reasonable expectation of success therein.
Further regarding Claim 1, McIntyre does not specifically teach the container cover discussed above wherein an aspiration tube is provided on a side of the holding plate facing away from the cove plate, extending from the holding plate, forming an extension of the through channel of the holding plate that is aligned with the through channel of the first port of the cover plate, wherein the aspiration tube comprises an elongated hollow body which extends essentially along a central axis and is adapted to provide a guiding structure for receiving a pipetting tip, as in Claim 12.
However, However, Maxim teaches a respective container for a biological sample wherein a tube 335 extends from a side of the holding plate 310, forming an extension of the channel 320, wherein the tube 335 directs liquid collected from the membrane to an intended delivery area while reducing risk of contamination to the sample by containing it within the tube 335 (Fig. 3B and [0067]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the container cover of McIntyre to include an aspiration tube provided on a side of the holding plate facing away from the cove plate, extending from the holding plate, forming an extension of the through channel, such as suggested by Maxim, so as to provide a sufficient structure to direct liquid collected from the membrane to an intended delivery area while reducing risk of contamination to the sample by containing it within the tube; and would have a reasonable expectation of success therein.
Further as in Claim 1, regarding the “wherein the aspiration tube comprises an elongated hollow body which extends essentially along a central axis and is adapted to provide a guiding structure for receiving a pipetting tip”, the tubes 335 extend essentially along a central axis, as each of the tubes are shown in Fig. 3A as being vertically oriented. Further, the tubes are fully equipped to act as a guiding structure for receiving a pipetting tip given that an operator could insert a pipette tip directly through the bottom of the tube 335 as seen through Fig. 4, or use a long pipette tip through the channels 320 to then be guided by the tubes 335.
As such, given that one of ordinary skill in the art would find it obvious to provide McIntyre with the aspiration tubes of Maxim as discussed above, the device of Maxim/McIntyre is commensurately configured wherein the aspiration tube comprises an elongated hollow body which extends essentially along a central axis and is adapted to provide a guiding structure for receiving a pipetting tip, as provided by Maxim.
Regarding Claim 2, the prior art meets the limitations of Claim 1 as discussed above. Further, McIntyre teaches the container cover discussed above wherein the second membrane is permeable for gas ([0031]: “The vented caps 110, 112 help to provide proper air pressure so as to allow for the insertion and extraction of the biological fluid…”) and liquid ([0031]: “…the size of the pores ranges between 0.2-10 μm…” – This range of pore sizes is sufficient for liquid to pass therethrough. Examiner notes Applicant discloses a pore size of 0.2 μm on page 6 line 6 of the instant specification.), as in Claim 2.
Regarding Claim 3, the prior art meets the limitations of Claim 1 as discussed above. Further, McIntyre teaches the container cover discussed above wherein a collar is provided on the circumference of the second port 108 on an outer side of the cover plate 116 extending essentially perpendicular to the cover plate 116 (Fig. 1A shows a collar for attaching cap 112 to the second port 108 as provided on the circumference of the second port 108 and extending upwardly/perpendicularly from the cover plate 116.), as in Claim 3.
Regarding Claim 4, the prior art meets the limitations of Claim 3 as discussed above. Further, McIntyre teaches the container cover discussed above comprising a fastening element provided on the exterior surface of the collar of the second port 108 (Fig. 1A shows the cap 112 as provided on the exterior surface of the collar via an extended portion, wherein the threads of the cap 112 complementary to the Luer lock 129 of the second port 108 is the fastening element.), as in Claim 4.
Regarding Claim 5, the prior art meets the limitations of Claim 1 as discussed above. Further, McIntyre teaches the container cover discussed above comprising a third port with a through channel extending through the entire thickness of the cover plate, wherein the third port is membrane-free (Fig. 1B and [0045]: “In an example embodiment, the penetrable flexible seal 114 (e.g., rubber stopper) can be removed so that other materials could be added to the biological-fluid container 102. For instance, in an example embodiment, a user can pull a rubber stopper out of the cap 104 to expose a hole in which the rubber stopper was positioned, and then insert other materials (e.g., tissue or fluid(s)) and/or instruments (e.g., a blender or blending apparatus) into the biological-fluid container 102 through that hole.” As such, the third port is membrane-free as it is merely covered by a removeable septum.), as in Claim 5.
Regarding Claim 6, the prior art meets the limitations of Claim 5 as discussed above. Further, McIntyre teaches the container cover discussed above wherein a collar is provided on a circumference of the third port on an outer side of the cover plate 116, extending essentially perpendicular to the cover plate 116 (Fig. 1A shows a collar surrounding flexible seal 114 as provided on the circumference of the third port, wherein this collar extends upwardly/perpendicularly from the cover plate 116.), as in Claim 6.
Regarding Claim 7, the prior art meets the limitations of Claim 6 as discussed above. Further, McIntyre teaches the container cover discussed above comprising a fastening element provided on an exterior surface of the collar of the third port (Fig. 1B shows the collar containing flexible seal 114, wherein the bottom of the collar comprises a flanged fastening element for securing the collar to the cover plate 116.), as in Claim 7.
Regarding Claim 9, the prior art meets the limitations of Claim 1 as discussed above. Further, McIntyre does not specifically teach the container cover discussed above wherein a diameter of each through channel of the holding plate is the same size as or is smaller than a corresponding diameter of the through channel of the cover plate, as in Claim 9.
However, the obvious combination of McIntyre and Ciliberto, as discussed above regarding Claim 8, provides for the above limitation as the aperture 38 of the cover plate 18 has a greater diameter than the aperture 26 of the holding plate 20 (Fig. 1).
Further, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the holding plate with an aperture lesser in diameter than the cover plate so as to provide a greater resistive force to a fluid compressing against the membrane, wherein the counter force is provided by the holding plate having a greater surface area due to the smaller aperture.
Regarding Claim 10, the prior art meets the limitations of Claim 1 as discussed above. Further, McIntyre does not specifically teach the container cover discussed above wherein a shoulder is formed in the through channel of the holding plate, on a channel end which is facing the cover plate, as in Claim 10.
However, the obvious combination of McIntyre and Ciliberto, as discussed above regarding Claim 8, provides for the above limitation as the holding plate 20 comprises a shoulder 24 for clamping the membrane 30 (Fig. 1 and [col., line]: “Flange 24 forms a support surface 28 within the end cap to support a porous membrane 30 which is placed within the end cap in overlying relation covering aperture 26.”).
Further, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the container cover of McIntyre with a holding plate having a shoulder, such as suggested by Ciliberto, so as to provide a sufficient opposing surface to the cover plate to clamp the membrane therebetween; and would have a reasonable expectation of success therein.
Regarding Claim 11, the prior art meets the limitations of Claim 1 as discussed above. Further, McIntyre does not specifically teach the container cover discussed above wherein a funnel is formed in the through channel of the holding plate that is aligned with the through channel of the second port of the cover plate, on a channel end which is facing the cover plate, as in Claim 11.
However, Maxim teaches a respective container for a biological sample wherein a membrane 350 is attached to the top of a funnel formed by a holding plate 310, wherein this arrangement allows the sample filtered through the membrane to be directed to an intended delivery area by the funnel (Fig. 3A and [0062-0064).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the container cover of McIntyre with a funnel structure aligned with the second port, such as suggested by Maxim, so as to provide a structure capable of collecting liquid filtered by the membrane and directing the liquid to an intended delivery area; and would have a reasonable expectation of success therein.
Regarding Claim 14, the prior art meets the limitations of Claim 1 as discussed above. Further, McIntyre teaches the container cover discussed above comprising a closed side wall which extends a multiple of a thickness of the cover plate from a circumference of the cover plate (Fig. 1B shows a cross-section of the cap wherein the dashed lines indicate the interior thicknesses of the cover plate. Herein, it is seen that the cover plate comprises a closed side wall extending from the circumference of the cover plate for sleeving over and attaching to the complimentary upper ring of the container 102.), as in Claim 14.
Regarding Claim 15, the prior art meets the limitations of Claim 14 as discussed above. Further, McIntyre teaches the container cover discussed above comprising a fastening element provided on an inward facing surface of the side wall ([0022]: “…the base 116 includes threads to attach to corresponding threads on the biological-fluid container 102.”), as in Claim 15.
Regarding Claim 16, the prior art meets the limitations of Claim 1 as discussed above. Further, McIntyre teaches the container cover discussed above wherein the second port comprises two or more second ports 106 and 108, wherein the two or more second ports are identical or different (Fig. 1B shows that the two second ports are different.), as in Claim 16.
Regarding Claim 17, the prior art meets the limitations of Claim 16 as discussed above. Further, McIntyre teaches the container cover discussed above wherein a gas permeable second membrane (“cap 110”) is arranged in one of the two or more second ports (Fig. 1C and [0004]: “…a cap can include a penetrable flexible seal configured for insertion and extraction of biological fluid through the flexible seal.” – The penetrable flexible seal is interpreted as a membrane given that a membrane is defined as “a thin soft pliable sheet or layer” (Merriam-Webster Dictionary).) and wherein a gas and liquid permeable second membrane is arranged in another of the two or more second ports ([0031]: “…the size of the pores ranges between 0.2-10 μm…” – This range of pore sizes is sufficient for liquid to pass therethrough. Examiner notes Applicant discloses a pore size of 0.2 μm on page 6 line 6 of the instant specification.), as in Claim 17.
Regarding Claim 18, the prior art meets the limitations of Claim 5 as discussed above. Further, McIntyre does not specifically teach the container cover discussed above wherein the first port comprises a plurality of first ports, wherein the second port comprises a plurality of second ports, wherein the third port comprises a plurality of third ports, and wherein the plurality of first ports, the plurality of second ports, and the plurality of third ports are arranged on the cover plate, as in Claim 18.
However, mere duplication of parts has no patentable significance unless a new and unexpected result is produced – see MPEP 2144.04(VI)(B).
Herein, one of ordinary skill in the art would find it obvious to provide several first/second/third ports arranged over a common cover plate if multiple port-interfaces are desired, such as multiple gas lines of different gasses attached to the ports.
Regarding Claim 27, the prior art meets the limitations of Claim 1 as discussed above. Further, McIntyre does not specifically teach the container cover discussed above wherein a length of the aspiration tube is configured such that a free end of the aspiration tube, facing away from the holding plate, at least partially touches a bottom of the fluid container when assembled with the fluid container, as in Claim 27.
However, the above claim recitation is drawn to a conditional (“when assembled with the fluid container”) process (touching two elements together) recitation that is both not necessitated by the claim and, as the claims are drawn to a device, such process recitation is not afforded patentable weight. "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II). Applicant may wish to rewrite the claim as a structural limitation such as by stating that the central cylindrical length of the aspiration tube is greater than the central cylindrical length of the container such that the claimed touching would occur when assembled.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over McIntyre in view of Smith, Ciliberto, and Maxim, as applied to Claims 1-7, 9, 11, 14-18, and 27 above, and in further view of Blankenstein et al. (US 2005/0249641 A1), referred to hereinafter as “Blankenstein”.
Regarding Claim 13, the prior art meets the limitations of Claim 1 as discussed above. Further, McIntyre does not specifically teach the container cover discussed above wherein at least one recess is formed in the aspiration tube on its free end facing away from the holding plate, as in Claim 13.
However, Blankenstein teaches a respective device wherein a capillary terminates at a tip comprising a wedge-shaped notch/recess; wherein this arrangement provides a structure capable of overcoming capillary forces and moving a liquid out of the capillary ([0188]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the container cover of McIntyre to include a wedge-shaped notch at the end of the tube, such as suggested by Blankenstein, so as to promote drainage of liquid from the tube, preventing any liquid from becoming stuck in the tube due to capillary/adhesive forces; and would have a reasonable expectation of success therein.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over McIntyre in view of Smith, Ciliberto, and Maxim, as applied to Claims 1-7, 9, 11, 14-18, and 27 above, and in further view of Trones et al. (US 2012/0186979 A1), hereinafter “Trones”.
Regarding Claim 26, the prior art meets the limitations of Claim 1 as discussed above. Further, McIntyre/Smith/Ciliberto/Maxim do not specifically teach the cover discussed above wherein the aspiration tube is constructed from an electrically conductive material, as in Claim 26.
However, Trones teaches a respective sample holder wherein an interior funnel (the aspiration tube) is constructed from a hollow fiber membrane having a tube like shape (Abstract) wherein said hollow-fiber membrane is electrically conductive so as to allow a current to be passed from an electrode inserted through the funnel to reach the sample so as to perform a measurement ([0014, 0029, 0067]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the container cover of McIntyre/Smith/Ciliberto/Maxim wherein the aspiration tube is constructed from an electrically conductive material, such as suggested by Trones, so as to enable electrical measurement of the liquid sample through the aspiration tube of the cover, thereby enabling assays related to electrical measurement of a sample such as pH determination, without necessarily contacting the sample directly, thereby alleviating risks of contamination.
Response to Arguments
Obviousness Rejections
Regarding the first obviousness rejections, Applicant’s arguments are on the alleged grounds that McIntyre, Smith, Ciliberto, and Maxim fail to teach the amended Claim 1 requirements of “wherein the aspiration tube comprises an elongated hollow body which extends essentially along a central axis and is adapted to provide a guiding structure for receiving a pipetting tip”. Applicant specifically further alleges that the aspiration tubes of Maxim are not described as in the claimed pipette-guiding structure.
Applicant’s arguments are not persuasive because, as discussed above in the body of the rejection, the aspiration tubes 335 of Maxim extend essentially along a central axis, as each of the tubes are shown in Fig. 3A as being vertically oriented. Further, the tubes are fully equipped to act as a guiding structure for receiving a pipetting tip given that an operator could insert a pipette tip directly through the bottom of the tube 335 as seen through Fig. 4, or use a long pipette tip through the channels 320 to then be guided by the tubes 335. As such, the tubes are commensurately adapted so as to provide a guiding structure for if an operator were to insert a pipette tip therethrough. The mere recitation of the intended guiding function does not patentably distinguish the claimed aspiration tube from the structurally corresponding and functionally capable tube of Maxim.
Thus, Examiner maintains the rejection of Claims 1-7, 9, 11, and 14-18 under 35 USC 103 as being unpatentable over McIntyre in view of Smith, Ciliberto, and Maxim.
Regarding the second obviousness rejection (of Claim 13), Applicant’s arguments are on the alleged grounds that Blankenstein further fails to cure the alleged deficiencies of the amended Claim 1 discussed above over McIntyre, Smith, Ciliberto, and Maxim.
However, Applicant’s arguments are not persuasive because, as discussed above, no such deficiencies are present in Claim 1. Thus, Claim 13 is not allowable merely for its dependence on Claim 1, and the prior art of Blankenstein is not relied upon for curing the alleged deficiencies of Claim 1.
New Claims 26 and 27
Claim 26 is rejected under 35 USC 103 as being unpatentable over McIntyre in view of Smith, Ciliberto, and Maxim as the claim is written as a process-type recitation based on a conditional not being afforded particular patentable weight herein.
Claim 27 is rejected under 35 USC 103 as being unpatentable over McIntyre in view of Smith, Ciliberto, and Maxim, and in further view of Trones, as discussed 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.
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/B.J.K./Examiner, Art Unit 1798 /NEIL N TURK/Primary Examiner, Art Unit 1798
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