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 Rejections - 35 USC § 112
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 13-20 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 13 recites the limitation "the media slurry”. There is insufficient antecedent basis for this limitation in the claim. This term has not previously been defined. Claims 14 and 20 are rejected as well since they depend on claim 13 and do not correct the deficiencies of claim 13.
Claim 13 recites the limitation "the basic column tube wall". There is insufficient antecedent basis for this limitation in the claim. The term “basic column wall” was previously deified; it is not clear if this refers to the same wall or a different “basic column tube wall”. Claims 14 and 20 are rejected as well since they depend on claim 13 and do not correct the deficiencies of claim 13.
Claim 15 recites the limitation "the closed second end”. There is insufficient antecedent basis for this limitation in the claim. This term was not previously defined. Claims 16-19 are rejected as well since they depend on claim 15 and do not correct the deficiencies of claim 15.
Claim 15 recites the limitation "the first end”. There is insufficient antecedent basis for this limitation in the claim. The term “a closed first end” was previously defined; it is not clear if this is the same or different first end. Claims 16-19 are rejected as well since they depend on claim 15 and do not correct the deficiencies of claim 15.
Claim 15 recites the limitation "the second end”. There is insufficient antecedent basis for this limitation in the claim. The term “the closed second end” was previously defined; it is not clear if this is the same or different second end. Claims 16-19 are rejected as well since they depend on claim 15 and do not correct the deficiencies of claim 15.
Claim 17 recites the limitation "a media slurry". There is insufficient antecedent basis for this limitation in the claim. This term was previously defined in claim 15; it is not clear if this is the same or a different media slurry.
Claim 18 recites the limitation "an extension tube wall”. There is insufficient antecedent basis for this limitation in the claim. This term was previously defined in claim 15; it is not clear if this is the same or a different extension tube wall.
Claim 18 recites the limitation "a basic column tube wall”. There is insufficient antecedent basis for this limitation in the claim. This term was previously defined in claim 15; it is not clear if this is the same or a different basic column tube wall.
Claim Rejections - 35 USC § 102
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 13, 15-16, and 18-19 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by English machine translation of JP2011/214880 by Satoshi (Satoshi).
Regarding limitations recited in the claims which are directed to a manner of operating disclosed chromatography column assembly, 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 sliding and sealing contact” (claim 13); “adapter is configured to compress the media slurry such that the media slurry remains compressed while securing the adapter to the basic column tube wall and separating the extension tube wall from the column tube wall” (claim 13); “single use” (claim 14); “for sliding and sealing contact” (claim 15); “the adaptor being moveable at least to a second position to reduce the internal volume, wherein in the second position the media inlet is no longer in fluid connection with the reduced internal volume” (claim 15); “whereint eh adaptor is configured to compress the media slurry such that the media slurry remains compressed while securing the adaptor to the basic column tube wall and separating the extension tube wall from the column tube wall” (claim 15).
In regard to claim 13, Satoshi teaches a chromatography column assembly ([0001]). Satoshi teaches a column tube having a closed first end comprising an outlet (Figure 1, bottom lid 6, liquid take out port 9; [0016]-[0024]). Satoshi teaches a media inlet adjacent a second end of the column tube (Figure 1, supply port 20; [0016]-[0024]). Satoshi teaches an adaptor positioned inside the column tube initially adjacent the second end of the column tube (Figure 1, movable plug 3; [0016]-[0024]); capable of sliding and sealing contact with an inner face of the column tube. Satoshi teaches the column tube and adaptor arranged initially such that they define an internal volume and such that the media inlet is in fluid connection with the internal volume (Figure 1, movable plug 3, supply port 20; [0016]-[0024]). Satoshi teaches the chromatography column is packed with chromatography media ([0001]).
Satoshi teaches the column tube comprises an extension tube wall (Figure 1, short cylindrical column joint 4; [0016]-[0024]) adjacent the second end (Figure 1, supply port 20; [0016]-[0024]) connected to a basic column wall adjacent the first end (Figure 1, column body 5; [0016]-[0024]). Satoshi teaches the adaptor is capable of compressing the media slurry such that the media slurry remains compressed while securing the adaptor to the basic column tube wall and separating the extension tube wall from the column tube wall (Figure 1, movable plug 3; [0016]-[0024]).
In regard to claim 15, Satoshi teaches a chromatography column assembly comprising a column tube having a first closed end comprising an outlet ((Figure 1, bottom lid 6, liquid take out port 9; [0016]-[0024]). Satoshi teaches a media inlet adjacent a second end of the column tube connectable to a media slurry source (Figure 1, supply port 20; [0016]-[0024]). Unger teaches an adaptor positionable in a first position inside the column tube adjacent the closed second end of the column tube for sliding and sealing contact with an inner face of the column tube (Figure 1, movable plug 3; [0016]-[0024]). Satoshi teaches the column tube and adaptor when arranged in said first position defining an internal volume where the media inlet is in fluid connection with the internal volume (Figure 1, movable plug 3, supply port 20; [0016]-[0024]). Satoshi teaches the adaptor is moveable at least to a second position to reduce the internal volume in which second portion the media inlet is no longer in fluid connection with the reduced internal volume (Figure 1, movable plug 3, supply port 20; [0016]-[0024]).
Satoshi teaches the column tube comprises an extension tube wall (Figure 1, short cylindrical column joint 4; [0016]-[0024] adjacent the second end (Figure 1, supply port 20; [0016]-[0024]) connected to a basic column wall adjacent the first end (Figure 1, column body 5; [0016]-[0024]). Satoshi teaches the adaptor is capable of compressing the media slurry such that the media slurry remains compressed while securing the adaptor the basic column tube wall and separating the extension tube wall from the column tube wall (Figure 1, movable plug 3; [0016]-[0024]).
In regard to claim 16, Satoshi teaches the adaptor comprises an inlet/outlet (Figure 1, liquid flow passage 15; [0019]; [0026]).
In regard to claim 18, Satoshi teaches the column tube comprises an extension tube wall comprising the media inlet connected to a basic column tube wall comprising the closed first end and wherein the first position of the adaptor is within the extension tube wall and the second position of the adaptor is within the basic column tube wall (Figure 1, short cylindrical column joint 4, column body 5; [0016]-[0024]).
In regard to claim 19, Satoshi teaches providing an air outlet in the column tube adjacent the second end of the column tube (Figure 1, outflow port 21; [0016]-[0024]).
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 14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over English machine translation of JP2011/214880 by Satoshi (Satoshi), as noted above, further in view of GB 2447344 by Gebauer.
In regard to claim 14 and 17, Satoshi teaches the limitations as noted above. Further, Satoshi teaches preventing contamination of foreign matter in the chromatographic column ([0013]; [0030]). Satoshi teaches a closed system ([0016]-[0024]).
Satoshi does not teach providing the system and the media slurry as pre-sterilized and providing aseptic and/or sanitary connectors to the media inlet.
Gebauer teaches a method of packing a chromatography system (abstract). Gebauer teaches closed systems are desirable for sanitary reasons (pg. 3, lines 16-21). Gebauer teaches aseptic conditions and pre-sterilized slurry (pg. 2, lines 16-21).
It would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate pre-sterilized media and sanitary connectors to the media inlets/outlets, as taught by Gebauer, in the method of Satoshi since it is known to have sanitary conditions in closed systems. One of ordinary skill in the art would be motivated to use pre-sterilized slurry and sanitary connectors in the method of Satoshi in order to prevent contamination.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over English machine translation of JP2011/214880 by Satoshi (Satoshi), as noted above.
In regard to claim 20, Satoshi teaches providing a column assembly packing apparatus including one or more closeable connectors at the end of one or more respective fluid paths ([0022]). Satoshi teaches the closeable connector prevents unwanted flow ([0022]).
Satoshi does not teach the closeable connector is complementary at least to the inlet/outlet. It would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate a closeable connector, as taught by Satoshi, complementary to the inlet/outlet of Satoshi in order to control flow conditions and prevent unwanted flow. It would have been obvious to one of ordinary skill in the art before the effective filing date to disconnect said one or more connectors at the end of the forcing step in order to create closed fluid paths in order to prevent any unwanted flow and seal the device.
Response to Arguments
Applicant's arguments filed 1/26/2026 have been fully considered but they are not persuasive.
In regard to the Applicant’s argument that Satoshi does not teach an adaptor configured to compress the media slurry such that the media slurry remains compressed while securing the adaptor; Satoshi does not teach remaining in a compressed position during separation of the two column portions; the Examiner does not find this persuasive.
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Further, as noted above: Satoshi teaches the adaptor is capable of compressing the media slurry such that the media slurry remains compressed while securing the adaptor the basic column tube wall and separating the extension tube wall from the column tube wall (Figure 1, movable plug 3; [0016]-[0024]).
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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/KARA M PEO/Primary Examiner, Art Unit 1777
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