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 .
Election/Restrictions
Applicant's election with traverse of species A1, B1, C1, and D1 in the reply filed on 6/2/2026 is acknowledged. The traversal is on the ground(s) that the claimed invention defines the search and not the drawings; the amended claims do not require the species distinctions; a search for any species will reveal non-elected species. This is not found persuasive because the species are mutually exclusive. Further, restriction is based on the specification.
The requirement is still deemed proper and is therefore made FINAL.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 1-5 and 8-18 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 1 recites the limitation "the outer surface”. There is insufficient antecedent basis for this limitation in the claim. This term has not previously been defined. Claims 2-5 and 8-18 are rejected as well since they depend on claim 1 and not rectify the indefiniteness issue.
Claim 1 recites the limitation "said inner component”. There is insufficient antecedent basis for this limitation in the claim. It is not clear if this refers to “cylindrical inner component” or a different inner component. Claims 2-5 and 8-18 are rejected as well since they depend on claim 1 and not rectify the indefiniteness issue.
Claim 1 recites the limitation "the connector”. There is insufficient antecedent basis for this limitation in the claim. Claims 2-5 and 8-18 are rejected as well since they depend on claim 1 and not rectify the indefiniteness issue.
Claim Interpretation
Claim 17 states “wherein the chromatography system comprises the releasable locking clamp”; claim 1 is interpreted as not requiring the releasable locking clamp. Claim 1 is interpreted to be capable of “receiving a releasable locking clamp” but does not require the particulars of the releasable locking clamp.
Claim Rejections - 35 USC § 103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 9-10, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Blomberg (US 8,821,718) in view of Maunder (US 2011/0089683).
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 and for further 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”, “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, wherein in a locking position of the connector, the locking component is mounted to the inner component, such that 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 connector, 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.
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.
Maunder discloses a retaining clamp for retaining a tube on a barbed connector (Abstract; Figure 5, tube 6 is connected to barbed connector 8 with barb 32 [0029]-[0034]). The barb has a sealing ridge such that the fluid tubing end creates a direct seal between the tubing inner wall and the sealing ridge (Figure 5, 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, Claim 2; wherein the widening of the spigot comprises a sealing ridge). Fluid connections in the food, medical and pharmaceutical industries are commonly made with flanged connectors clamped to each other, and the connectors have hollow spigots to which the tube is connected ([0005]).
Maunder discloses a spigot 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, 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. (Figure 5, [0034], Abstract, collet 2 (cylindrical inner component) comprises fingers with inward projections 18 (resiliently deflectable portion) which urge the tube against the connector behind the barb (arranged to urge an outer surface of the fluid tubing toward a respective spigot; wherein the resiliently deflectable portion of the inner component comprises plural circumferentially arranged fingers which are deflectable inwardly in use, Claim 3)). It would be obvious to one of ordinary skill in the art to make the locking clamp releasable in order to remove the tubing from the spigot and reuse the locking clamp and the spigot, thus reducing costs and waste.
Maunder discloses 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 (Figure 5, [0029]-[0034], sleeve 4 (locking component) has an internal through-aperture for slideably accepting the collet 2 (cylindrical inner component), the sleeve 4 comprising inward projections 28 which are designed to mate with the projections 19 of the collet 2 and lock the collet and sleeve together, urging the fingers of the collet inwards and together (the internal through- aperture and resiliently deflectable portion having complementary surface formations which in a first position of the collar element mounted to the inner component provide for said resilient deflection 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); when the projections of the sleeve and collet are not locked together, the sleeve and collet are in the second position (and which in a second different position do not cause said deflection)).
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 Maunder, in order to seal fluid tubing to a spigot via a locking clamp, as is common in the art.
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.
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 Maunder (US 2011/0089683), 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).
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over
Blomberg (US 8,821,718) in view of Maunder (US 2011/0089683), as applied to the claims above, and in further view of Graham et al (US 2016/0305586).
With regard to Claims 14 and 15, modified Blomberg discloses all the limitations in the claims as set forth above. However, 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.
Conclusion
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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/KARA M PEO/Primary Examiner, Art Unit 1777
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