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 .
Notes
All the objections and rejections in the previous Office Action not reiterated herein have been withdrawn.
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 30 and 31 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 30 recites the limitation "the valve" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 31 recites the limitation "the controller" in line 12. There is insufficient antecedent basis for this limitation in the claim.
Appropriate correction is required.
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.
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 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 11,027239; hereinafter “Zhang”) in view of Taniguchi et al. (already of record, US 10,113,144; hereinafter “Taniguchi”).
Regarding claim 29, Zhang discloses a cell suspension treatment apparatus configured to perform a concentration treatment on a cell suspension, the cell suspension treatment apparatus comprising: a circulation circuit configured to circulate the cell suspension (FIG. 2: main loop pathway (46); [0037]); and a cell suspension supply source configured to supply the cell suspension to the circulation circuit (FIG. 2: source bag (16) supplying cells to the main loop pathway (46); [0028], [0031], [0038]); wherein the circulation circuit includes a filter membrane that filters and concentrates the cell suspension (FIG. 2: crossflow filtration device (18); [0031], [0036]-[0037]), a reservoir that includes an inlet port and an outlet port, and is configured to store the cell suspension (FIG. 2: process bag (20); [0030], [0032]) and, a pump that circulates the cell suspension (FIG. 2: pump (36) adapted to maintain flow of process volume from the process bag (20) to the filter membrane (18) and from the filter membrane to the process bag (20)), wherein the cell suspension supply source is connected to a portion of the circulation circuit on the downstream side of the reservoir relative to the circulation direction and on an upstream side of the pump relative to the circulation direction (see FIG. 1: source bag (16) is arranged between an outlet (22) of process bag (20) and upstream of the pump (36)). Zhang does not explicitly disclose wherein filter membrane is a hollow fiber membrane. Taniguchi discloses a cell suspension treatment apparatus comprising a circulation circuit (FIG. 1: circuit (30); col. 14, ll. 42-46), a cell suspension supply source (FIG. 1: bag coupled to valve (22); col. 13, ll. 32-39), a reservoir (FIG. 1: container (3); col. 13, ll. 31-42), a hollow fiber membrane filter (FIG. 1: cell suspension treatment device (6); col. 14, ll. 4-7 and 22-23). In view of Taniguchi, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the filter membrane of Zhang with the filter membrane of Taniguchi to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill in the art would have made said modification because said modification would have been the simple substitution of one known filtration means for another for the predictable result of filtering biological materials. See also MPEP Section 2144.07. Zhang discloses the claimed pump and the function of pump is to maintain flow of process volume from the process bag (20) to the filter membrane (18) and from the filter membrane to the process bag (20). Zhang, however, does not explicitly disclose wherein the pump is provided on a downstream side of the reservoir relative to a circulation direction of the cell suspension and on an upstream side of the hollow fiber membrane filter relative to the circulation direction. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the pump of Zhang such that the pump is provided on a downstream side of the reservoir relative to a circulation direction of the cell suspension and on an upstream side of the hollow fiber membrane filter relative to the circulation direction (e.g., pump is placed downstream of the flow loop (50)), since it has been held that a mere rearrangement of element without modification of the operation of the device involves only routine skill in the art (i.e., pump still function as means for maintaining flow of process volume from the process bag (20) to the filter membrane (18) and from the filter membrane to the process bag (20), as required by Zhang). See also MPEP § 2144.04 VI. C. Furthermore, it is noted that the recitation of functional language "e.g., to perform a concentration treatment on a cell suspension" is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed apparatus and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 30, modified Zhang discloses a filling liquid supply source connected to a portion of the circulation circuit (FIG. 2: bag (22) for supplying buffer to the circulation circuit and bag (20); [0030]) on the upstream side of the pump (modified apparatus of Zhang includes a pump (36) arranged downstream of the bag (20) and thus bag (22) would be arranged upstream of pump (36); see rejection of claim 29 above); and a controller configured to control the pump (fluid management system (12) coupled to the pump; [0030], [0035]); wherein after the hollow fiber membrane filter concentrates the cell suspension and the reservoir stores the cell suspension, the controller controls and the pump to be driven in the circulation direction, such that the filling liquid supply source starts supplying a filling liquid to the circulation circuit to push the cell suspension from the pump toward the inlet port of the reservoir in the circulation direction (FIG. 2: bag (22) for supplying buffer to the circulation circuit and to the bag (20); [0030], [0035]). Modified Zhang does not explicitly disclose wherein a valve arranged on upstream side of the filling liquid supply source. However, Zhang does disclose wherein valves can be employed with tubings of the apparatus ([0030], [0036]). It would therefore have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have employed a valve with the apparatus of modified Zhang such that the filling liquid supply source is connected to a portion of the circulation circuit on a downstream side of the valve to arrive at the claimed invention. One of ordinary skill in the art would have made said modification for the purpose of regulating fluid flow through the circulation circuit as suggested by Zhang ([0030], [0036]). Further, making parts separable or rearranging parts is prima facie obvious absent evidence to the contrary. See M.P.E.P. § 2144.04 VI (C).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang in view of Taniguchi as applied to claim 29 above, and further in view of Martin (US 9,758,755) and Zhou et al. (US 2015/0158907; hereinafter “Zhou”).
Regarding claim 31, modified Zhang further discloses a filling liquid supply source that supplies a filling liquid to the hollow fiber membrane filter in the circulation circuit (FIG. 2: bag (22) for supplying buffer to the circulation circuit and thus to the filter (18); [0030]); the controller controls the pump (fluid management system (12) coupled to the pump; [0030], [0035]). Modified Zhang does not explicitly disclose wherein the pump to be driven in a reverse direction that is opposite to the circulation direction. Zhou discloses an apparatus comprising, a circulation circuit (FIG. 1), a reservoir (FIG. 1: reservoir 2), a filter (12), and a bidirectional pump (8) coupled to the circulation circuit. Martin discloses an apparatus comprising a cell suspension (FIG. 1: 102), a reservoir (FIG. 1: 144), a filter (104), a filling liquid supply source (136,140), and a pump that can be driven in a reverse direction (pump 112) for supply fluid from the filling liquid supply source. In view of Martin, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the pump of modified Zhang with the pump of Martin to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill in the art would have made said modification because said modification would have resulted in an apparatus having the added advantage of reversing flow through the circulation circuit and thereby direct desired fluid to the desired component of the apparatus. Further, one of ordinary skill in the art would have made said modification for the purpose of increasing the throughput of the apparatus as disclosed by Zhou ([0005]). Regarding the limitations “wherein after the hollow fiber membrane filter concentrates the cell suspension and the reservoir stores the cell suspension … such that the filling liquid supply source starts supplying the filling liquid to the hollow fiber membrane filter to push the cell suspension from the hollow fiber membrane filter toward the outlet port of the reservoir to the pump in the reverse direction,” it is noted that the bidirectional pump of modified Zhang is structurally the same as the instant pump and thus considered to be capable of meeting said limitations. Further, said limitations are directed to a manner of operating disclosed apparatus, 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.
Allowable Subject Matter
Claims 21 and 23-28 are allowed.
Response to Arguments
Applicant’s arguments with respect to claims 29-31 have been considered but are moot in view of the new ground of rejection. Applicant’s amendment changed the scope of claims 29-31.
In response to the Applicant’s argument that Ladisch does not disclose a cell supply source that is connected to the circulation circuit “from outside” (see Remarks at page 10), it is noted that claims 29-31 are currently presented do not specify how the cell supply source is connected to the circulation circuit. That is, the claims do not require the configuration the Applicant contends.
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 LIBAN M HASSAN whose telephone number is (571)270-7636. The examiner can normally be reached on 8:30 AM - 5:00 PM.
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, Michael Marcheschi can be reached on 5712721374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LIBAN M HASSAN/Primary Examiner, Art Unit 1799
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