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 .
Claim Status
Claims 1-5 and 8-18 are pending.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5 and 8-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regard to claim 1, the limitation “wherein the locking component and the cylindrical inner component do not comprise an interlocking ratchet mechanism” is considered new matter. There is no support for this limitation in the instant specification or instant drawings. Applicant points to paragraphs [0041]; [0126]; [0043]; [0128]-[0130]; [0058]; [0060]-[0061] as providing support for not comprising an interlocking ratchet mechanism. The Examiner does not agree. Multiple places in the instant specification detail a locking feature ([0023]; [0040]; [0044]; [0048]). The term “ratchet” is defined according to dictionary.com as “a toothed bar with which a pawl engages” (RATCHET Definition & Meaning | Dictionary.com). While the paragraphs cited do not include a “ratchet” they also do not provide support for the scope of “wherein the locking component and the cylindrical inner component do not comprise an interlocking ratchet mechanism”. Claims 2-5 and 8-18 are rejected as well since they depend from claim 1 and do not rectify the issues of claim 1.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 17 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 17 requires “the chromatography system comprises the releasable locking clamp”; this is already required in claim 1; therefore, the claim is not further limiting. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-5, 9-10, and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Blomberg (US 8,821,718) in view of Graham et al (US 2016/0305586).
Regarding limitations recited in the claims which are directed to a manner of operating disclosed chromatography system, it is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2114 and 2115. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Claim analysis is highly fact-dependent. A claim is only limited by positively recited elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935). This applies to the following limitations: “for receiving a respective end of the fluid tubing”; “for applying a radial locking force on an outer surface of the end of the fluid tubing for locking the end of the fluid tubing on the spigot”, “for accepting the fluid tubing”; “arranged to urge an outer surface of the fluid tubing toward a respective spigot”; “for accepting the cylindrical inner component”; “the locking component applies a clamping force on the resiliently deflectable portion which is deflected inwardly and thereby applies the radial locking force on the outer surface of the end of the fluid tubing, and wherein in a release position of the releasable locking clamp, the deflectable portion springs resiliently outwardly thereby releasing the radial locking force on the outer surface of the end of the fluid tubing” (claim 1), “the clamping force is generated by a movement linear motion of the locking component along the inner component towards the fluid handling component” (claim 4), “the clamping force is generated by a linear motion is a sliding motion of the locking component along the inner component” (claim 5), “the chromatography system is configured for use in Good Manufacturing Practice (GMP)- environments” (claim 18).
In regard to claims 1-3, Blomberg teaches a chromatography system comprising plural fluid handling components fluidically interconnectable by fluid tubing to form a bioprocess fluid flow path (Abstract; Figure 10, C8/L43-56, Figure 10 shows an embodiment of a fluidic interconnection arrangement with tubing arranged to interconnect the different component modules of the system). Blomberg teaches said fluid handling components comprising one or more fluid ports (Figure 10, C8/L43-56, Figure 10 shows an embodiment of a fluidic interconnection arrangement with tubing arranged to interconnect the different component modules of the system).
Blomberg is silent to the one or more fluid ports having a spigot extending from a face of the fluid handling components and for receiving a respective end of the fluid tubing and capable of receiving a releasable locking clamp for applying a radial locking force on the outer surface of the tubing end for locking the end of the fluid tubing on the spigot. Blomberg is silent regarding the spigot is provided with an open end having a widening in proximity to the open end, wherein the end of the fluid tubing is arranged to be in sealing engagement with the widening around the outer surface of the spigot.
Graham teaches one or more fluid ports having a spigot extending from a face of the fluid handling components and for receiving a respective end of the fluid tubing and capable of receiving a releasable locking clamp for applying a radial locking force on the outer surface of the tubing end for locking the end of the fluid tubing on the spigot (Figure 2, housing body 21, threaded portion 22, first end 30; [0084]-[0090]). Graham teaches the spigot is provided with an open end having a widening in proximity to the open end, wherein the end of the fluid tubing is arranged to be in sealing engagement with the widening around the outer surface of the spigot (Figure 2, housing body 21, threaded portion 22, first end 30; [0084]-[0090]). Graham teaches the locking component and the cylindrical inner component do not comprise an interlocking ratchet mechanism (Figure 2; [0084]-[0090]).
Graham teaches the widening of the spigot comprises a sealing ridge (Figure 2, housing body 21, threaded portion 22, first end 30; [0084]-[0090]; reading on claim 2).
Graham teaches the resiliently deflectable portion of the cylindrical inner component comprises plural circumferentially arranged finger which are deflectable inwardly in the locking position (Figure 2, threaded portion 9; [0084]-[0090]; reading on claim 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the one or more fluid ports of Blomberg to have a spigot extending from a component face and for receiving a respective end of the fluid tubing such that the fluid tubing end sealingly embraces the spigot and for receiving a releasable locking clamp for applying a radial locking force on an outer surface of the tubing end for locking the end of the fluid tubing on the spigot, and wherein the releasable locking clamp comprises a cylindrical inner component for accepting the fluid tubing, said inner component including a resiliently deflectable portion arranged to urge an outer surface of the fluid tubing toward a respective spigot, and a locking component having an internal through-aperture for accepting the inner component, the through- aperture and resiliently deflectable portion having complementary surface formations which in a first position of the locking element mounted to the inner component provide for resilient deflection in use, and which in a second different position do not cause said deflection, wherein the spigot is provided with an open end having a widening in proximity to the open end, wherein the end of the fluid tubing is arranged to be in sealing engagement with the widening around the outer surface of the spigot, wherein the resiliently deflectable portion of the inner component comprises plural circumferentially arranged fingers which are deflectable inwardly in use, wherein a clamping force is applied on the resiliently deflectable portion of the inner component in the first position of the locking element (Claim 5), wherein the widening of the spigot comprises a sealing ridge, wherein the fluid ports are arranged as non-threaded holes having the spigot protruding from the front face of the at least one fluid handling component, as taught by Graham, in order to seal fluid tubing to a spigot via a locking clamp, as is common in the art to prevent leak proof connections.
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the locking clamp to be releasable, in order to remove the tubing from the spigot and reuse the locking clamp and the spigot, thus reducing costs and waste.
In regard to claim 9, modified Blomgberg is silent that the fluid tubing has a resting size of an inner diameter that is less than +10% of an outer diameter of the spigot.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein the fluid tubing has a resting size of an inner diameter that is less than +/- 10% of an outer diameter of the spigot, so that the fluid tubing can form a seal on the spigot.
In regard to claim 10, modified Blomberg is silent to wherein the interconnection withstands at least 10 bar, or 15, 20, 25, or 30 bar.
Blomberg discloses that the maximum operating pressure of the system pumps is about 20 mPa, which is about 200 bar (C3/L5-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein the interconnection withstands at least 10 bar, or 15, 20, 25, or 30 bar, as taught by Blomberg, in order for the spigot and tubing interconnection to be pressurizable up to 30 bar while the interconnection seal is maintained, since the system of Blomberg operates within this range.
In regard to claim 16, Blomberg teaches the fluid handling components are at least one of the following: an outlet valve, an inlet valves, an air trap valve, a column valve, a mixer valve and a pump (Figure 1, C2/L41-63).
In regard to claim 17, modified Blomberg teaches the chromatography system comprises the releasable locking clamp as noted above.
With regard to Claims 14 and 15, modified Blomberg is silent to wherein the fluid tubing is formed of a substantially rigid material (Claim 14), wherein the substantially rigid material comprises Fluorinated EtenPropen (FEP) plastic (Claim 15).
Graham et al (Graham) discloses a manifold assembly has a manifold and can be located between a block and a plate, and serve as a stator for a valve or other component (Abstract). Graham discloses that the stator for a valve may be part of a liquid chromatography system ([0034]), and that associated tubing may be made from fluorinated ethylene propylene (FEP), among other choices, which are biocompatible ([0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein the fluid tubing is formed of a substantially rigid material (Claim 13), wherein the substantially rigid material comprises Fluorinated EtenPropen (FEP) plastic (Claim 14), as taught by Graham, for biocompatible applications in the chromatography system of modified Blomberg.
Claims 8 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Blomberg (US 8,821,718) in view of Graham et al (US 2016/0305586), as noted above, in view of Roose et al (US 2015/0290610), Zacharias (US 2008/0319451), or Yoo (US 2008/0183156).
In regard to claim 8, modified Blomberg teaches the limitations as noted above. Blomberg is silent to wherein the fluid tubing has an outside diameter of around 3 to 10 mm.
Such fluid tubing is well known across arts. Roose discloses flexible PVC tubing with an internal diameter of 3.2 mm and outer diameter of 4.8 mm ([0151]). Zacharias discloses silicone tubing having 3.2 mm ID and 4.8 mm OD ([0081]). Yoo discloses that drainage tubes can have an outer diameter of 4.8 mm and an inner diameter of 3.2 mm ([0024]).
Furthermore, the Federal Circuit held that, where 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 dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP § 2144.04(IV)(A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein the fluid tubing has an outside diameter of around 3 to 10 mm, as taught by Roose, Zacharias, or Yoo, since where 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 dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP § 2144.04(IV)(A).
In regard to claims 11-13, modified Blomberg teaches the limitations as noted above.
Modified Blomberg is silent to wherein the fluid tubing has an inner diameter of 3.2 mm and an outer diameter of 4.8 mm, and the spigot has a base diameter of 3.25 mm and the sealing ridge a diameter of 3.45 mm.
Such fluid tubing is well known across arts. Roose discloses flexible PVC tubing with an internal diameter of 3.2 mm and outer diameter of 4.8 mm ([0151]). Zacharias discloses silicone tubing having 3.2 mm ID and 4.8 mm OD ([0081]). Yoo discloses that drainage tubes can have an outer diameter of 4.8 mm and an inner diameter of 3.2 mm ([0024]).
Furthermore, with regard to both the fluid tubing and spigot dimensions, the Federal Circuit held that, where 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 dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP § 2144.04(IV)(A).
Finally, it would be obvious for the sealing ridge of the spigot to be wide enough for the fluid tubing to form a seal around the sealing ridge, but not too wide such that the fluid tubing would not be able to fit over the sealing ridge.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein the fluid tubing has an inner diameter of 3.2 mm and an outer diameter of 4.8 mm, and the spigot has a base diameter of 3.25 mm and the sealing ridge a diameter of 3.45 mm, as taught by Roose, Zacharias, or Yoo, in order for the fluid tubing to form a seal with the sealing ridge of the spigot, and since where 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 dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP § 2144.04(IV)(A).
Response to Arguments
Applicant's arguments filed 9/9/2026 have been fully considered but they are not persuasive. The arguments are directed towards prior art that is no longer included in the current rejection. The prior art rejection has been updated in light of the claim amendments.
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 KARA M PEO whose telephone number is (571)272-9958. The examiner can normally be reached 9 to 5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Claire Wang can be reached at (571) 270-1051. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA M PEO/Primary Examiner, Art Unit 1777
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